FDA · Medical device recall

Aisys Anesthesia System… and 2 more products

Nov. 21, 2018 Class II

Date: Nov. 21, 2018
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: GE Healthcare, LLC
Reason: Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breathing Modes do not provide the PSVPro ventilation mode feature of transitioning to SIMV PCV backup ventilation mode. PSVPro Spontaneous Breathing Modes do not provide the feature of transitioning to SIMV PCV backup ventilation mode for a patient who stops spontaneous breathing if the PSVPro ventilation mode is in use prior to the clinician starting the Cycling Procedure.
Distribution pattern: Worldwide distribution - US nationwide in the states of CA, CO, DC, FL, GA, HI, IA, IL, IN, KY, LA, ,MA, MD, MI, MN, MO, MT, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Countries of Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea (Republic of), Kuwait, Macedonia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Peru, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

3 products in this recall

Aisys Anesthesia System…

Product: Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE.
Quantity: 4,207 units total
Codes and lots: Model Number, UDI Number, (Serial Number): 2097674-001-US, Not Applicable, (5470345-30); 2097674-001-US, Not Applicable, (5470345-31); 2097674-001-US, Not Applicable, (5470345-32); 1011-9000-000, Not Applicable, (ANAK00774); 1011-9000-000, Not Applicable, (ANAK00775); 1011-9000-000, Not Applicable, (ANAL01201); 1011-9000-000, Not Applicable, (ANAL01234); 1011-9000-000, Not Applicable, (ANAL01235); 1011-9000-000, Not Applicable, (ANAL01236); 1011-9000-000, Not Applicable, (ANAL01237); 1011-9000-000, Not Applicable, (ANAL01238); 1011-9000-000, Not Applicable, (ANAL01240); 1011-9000-000, Not Applicable, (ANAL01494); 1011-9000-000, Not Applicable, (ANAL01495); 1011-9000-000, Not Applicable, (ANAL01551); 1011-9000-000, Not Applicable, (ANAM01023); 1011-9000-000, Not Applicable, (ANAM01024); 1011-9000-000, Not Applicable, (ANAM01025); 1011-9000-000, Not Applicable, (ANAM01026); 1011-9000-000, Not Applicable, (ANAM01027); 1011-9000-000, Not Applicable, (ANAM01104); 1011-9000-000, Not Applicable, (ANAM01105); 1011-9000-000, Not Applicable, (ANAP00438); 1011-9000-000, Not Applicable, (ANAP00439); 1011-9000-000, Not Applicable, (ANAQ01188); 1011-9000-000, Not Applicable, (ANAR05264); 1011-9000-000, Not Applicable, (ANAR05265); 1011-9000-000, Not Applicable, (ANAR05610); 1011-9000-000, Not Applicable, (ANAR05611); 1011-9000-000, Not Applicable, (ANAS00202); 1011-9000-000, Not Applicable, (ANAS00203); 1011-9000-000, Not Applicable, (ANAS00204); 2097674-001-US, Not Applicable, (5479630-1); ANAK00798, Not Applicable (1011-9000-000); ANAK00799, Not Applicable (1011-9000-000); ANAK00803, Not Applicable (1011-9000-000); ANAK00807, Not Applicable (1011-9000-000); ANAK00814, Not Applicable (1011-9000-000); ANAK00839, Not Applicable (1011-9000-000); ANAK00864, Not Applicable (1011-9000-000); 5481223-1, Not Applicable (2097674-001-US); 5481223-10, Not Applicable (2097674-001-US); 5481223-11, Not Applicable (2097674-001-US); 5481223-12, Not Applicable (2097674-001-US); 5481223-2, Not Applicable (2097674-001-US); 5481223-3, Not Applicable (2097674-001-US); 5481223-4, Not Applicable (2097674-001-US); 5481223-5, Not Applicable (2097674-001-US); 5481223-6, Not Applicable (2097674-001-US); 5481223-7, Not Applicable (2097674-001-US); 5481223-8, Not Applicable (2097674-001-US); 5481223-9, Not Applicable (2097674-001-US); ANAP00712, Not Applicable (1011-9000-000); ANAP00713, Not Applicable (1011-9000-000); ANAP00714, Not Applicable (1011-9000-000); ANAN01125, Not Applicable (1011-9000-000); ANAN01138, Not Applicable (1011-9000-000); 4652664-1, Not Applicable (2097674-001-US); 4652664-10, Not Applicable (2097674-001-US); 4652664-11, Not Applicable (2097674-001-US); 4652664-12, Not Applicable (2097674-001-US); 4652664-13, Not Applicable (2097674-001-US); 4652664-2, Not Applicable (2097674-001-US); 4652664-3, Not Applicable (2097674-001-US); 4652664-4, Not Applicable (2097674-001-US); 4652664-5, Not Applicable (2097674-001-US); 4652664-6, Not Applicable (2097674-001-US); 4652664-7, Not Applicable (2097674-001-US); 4652664-8, Not Applicable (2097674-001-US); 4652664-9, Not Applicable (2097674-001-US); ANAK00156, Not Applicable (1011-9000-000); ANAK00157, Not Applicable (1011-9000-000); ANAK00158, Not Applicable (1011-9000-000); ANAK00159, Not Applicable (1011-9000-000); ANAK00511, Not Applicable (1011-9000-000); ANAK00512, Not Applicable (1011-9000-000); ANAK00513, Not Applicable (1011-9000-000); ANAK00514, Not Applicable (1011-9000-000); ANAN01051, Not Applicable (1011-9000-000); ANAN01052, Not Applicable (1011-9000-000); ANAP00545, Not Applicable (1011-9000-000); ANAP00546, Not Applicable (1011-9000-000); ANAP00708, Not Applicable (1011-9000-000); ANAL01400, Not Applicable (1011-9000-000); ANAL01401, Not Applicable (1011-9000-000); ANAM00449, Not Applicable (1011-9000-000); ANAM01089, Not Applicable (1011-9000-000); 5453450-1, Not Applicable (2097674-001); 5453450-2, Not Applicable (2097674-001); 5453450-3, Not Applicable (2097674-001); 5453450-4, Not Applicable (2097674-001); 5453450-5, Not Applicable (2097674-001); 5453450-6, Not Applicable (2097674-001); 5453450-7, Not Applicable (2097674-001); 5453450-8, Not Applicable (2097674-001); 5480532-1, Not Applicable (2097674-001); 5447751-1, Not Applicable (2097674-001); 5447751-10, Not Applicable (2097674-001); 5447751-11, Not Applicable (2097674-001); 5447751-12, Not Applicable (2097674-001); 5447751-13, Not Applicable (2097674-001); 5447751-14, Not Applicable (2097674-001); 5447751-15, Not Applicable (2097674-001); 5447751-16, Not Applicable (2097674-001); 5447751-17, Not Applicable (2097674-001); 5447751-18, Not Applicable (2097674-001); 5447751-19, Not Applicable (2097674-001); 5447751-2, Not Applicable (2097674-001); 5447751-20, Not Applicable (2097674-001); 5447751-21, Not Applicable (2097674-001); 5447751-22, Not Applicable (2097674-001); 5447751-23, Not Applicable (2097674-001); 5447751-24, Not Applicable (2097674-001); 5447751-3, Not Applicable (2097674-001); 5447751-4, Not Applicable (2097674-001); 5447751-5, Not Applicable (2097674-001); 5447751-6, Not Applicable (2097674-001); 5447751-7, Not Applicable (2097674-001); 5447751-8, Not Applicable (2097674-001); 5447751-9, Not Applicable (2097674-001); 5452649-1, Not Applicable (2097674-001); 5452649-2, Not Applicable (2097674-001); 5474323-1, Not Applicable (2097674-DE); ANAR05021, Not Applicable (1011-9000-000); 5473625-5, Not Applicable (2097674-NL); 5473625-6, Not Applicable (2097674-NL); 5473625-7, Not Applicable (2097674-NL); ANAK00330, Not Applicable (1011-9000-000); ANAK00332, Not Applicable (1011-9000-000); ANAK00334, Not Applicable (1011-9000-000); ANAL00806, Not Applicable (1011-9000-000); ANAL00807, Not Applicable (1011-9000-000); ANAL00808, Not Applicable (1011-9000-000); ANAL00809, Not Applicable (1011-9000-000); ANAN01010, Not Applicable (1011-9000-000); ANAN01011, Not Applicable (1011-9000-000); ANAN01012, Not Applicable (1011-9000-000); ANAN01013, Not Applicable (1011-9000-000); ANAN01014, Not Applicable (1011-9000-000); ANAP00399, Not Applicable (1011-9000-000); ANAP01133, Not Applicable (1011-9000-000); ANAR00344, Not Applicable (1011-9000-000); ANAR00896, Not Applicable (1011-9000-000); ANAR05978, Not Applicable (1011-9000-000); ANAR05979, Not Applicable (1011-9000-000); ANAR05980, Not Applicable (1011-9000-000); ANAR05981, Not Applicable (1011-9000-000); ANAR05982, Not Applicable (1011-9000-000); ANAR05983, Not Applicable (1011-9000-000); ANAR05984, Not Applicable (1011-9000-000); ANAS00709, Not Applicable (1011-9000-000); ANAS00710, Not Applicable (1011-9000-000); ANAS00711, Not Applicable (1011-9000-000); 5472401-2, Not Applicable (2097674-001); ANAP00132, Not Applicable (1011-9000-000); 5472557-4, Not Applicable (2097674-001); 5472557-5, Not Applicable (2097674-001); 5472557-6, Not Applicable (2097674-001); ANAN01045, Not Applicable (1011-9000-000); ANAN01046, Not Applicable (1011-9000-000); ANAR00327, Not Applicable (1011-9000-000); ANAS00345, Not Applicable (1011-9000-000); 5454764-3, Not Applicable (2097674-001); ANAP00584, Not Applicable (1011-9000-000); ANAP00585, Not Applicable (1011-9000-000); ANAP00586, Not Applicable (1011-9000-000); ANAP00587, Not Applicable (1011-9000-000); ANAP00588, Not Applicable (1011-9000-000); ANAP00589, Not Applicable (1011-9000-000); ANAP00825, Not Applicable (1011-9000-000); ANAP01215, Not Applicable (1011-9000-000); ANAS00738, Not Applicable (1011-9000-000); ANAL01390, Not Applicable (1011-9000-000); ANAL01391, Not Applicable (1011-9000-000); ANAS00391, Not Applicable (1011-9000-000); ANAR00492, Not Applicable (1011-9000-000); ANAR00493, Not Applicable (1011-9000-000); ANAR00494, Not Applicable (1011-9000-000); ANAR00495, Not Applicable (1011-9000-000); ANAR00496, Not Applicable (1011-9000-000); ANAR00497, Not Applicable (1011-9000-000); ANAR00498, Not Applicable (1011-9000-000); ANAR00499, Not Applicable (1011-9000-000); ANAR00500, Not Applicable (1011-9000-000); ANAR00501, Not Applicable (1011-9000-000); ANAR00756, Not Applicable (1011-9000-000); ANAR00757, Not Applicable (1011-9000-000); ANAL00705, Not Applicable (1011-9000-000); ANAL01040, Not Applicable (1011-9000-000); ANAL01041, Not Applicable (1011-9000-000); ANAL01042, Not Applicable (1011-9000-000); ANAL01043, Not Applicable (1011-9000-000); ANAL01044, Not Applicable (1011-9000-000); ANAL01045, Not Applicable (1011-9000-000); ANAL01046, Not Applicable (1011-9000-000); ANAL01047, Not Applicable (1011-9000-000); ANAL01048, Not Applicable (1011-9000-000); ANAL01050, Not Applicable (1011-9000-000); ANAM00335, Not Applicable (1011-9000-000); ANAL00192, Not Applicable (1011-9000-000); ANAL00754, Not Applicable (1011-9000-000); ANAL00755, Not Applicable (1011-9000-000); ANAL00756, Not Applicable (1011-9000-000); ANAL00757, Not Applicable (1011-9000-000); ANAL00764, Not Applicable (1011-9000-000); ANAL00769, Not Applicable (1011-9000-000); ANAL00776, Not Applicable (1011-9000-000); ANAL00777, Not Applicable (1011-9000-000); ANAL00778, Not Applicable (1011-9000-000); ANAL00779, Not Applicable (1011-9000-000); ANAL00780, Not Applicable (1011-9000-000); ANAL00781, Not Applicable (1011-9000-000); ANAL00782, Not Applicable (1011-9000-000); ANAL00783, Not Applicable (1011-9000-000); ANAL00784, Not Applicable (1011-9000-000); ANAL00785, Not Applicable (1011-9000-000); ANAL00786, Not Applicable (1011-9000-000); ANAL00787, Not Applicable (1011-9000-000); ANAL00788, Not Applicable (1011-9000-000); ANAL00789, Not Applicable (1011-9000-000); ANAL00790, Not Applicable (1011-9000-000); ANAL00791, Not Applicable (1011-9000-000); ANAL00792, Not Applicable (1011-9000-000); ANAL01541, Not Applicable (1011-9000-000); ANAL01542, Not Applicable (1011-9000-000); ANAP00810, Not Applicable (1011-9000-000); ANAP00811, Not Applicable (1011-9000-000); ANAS00938, Not Applicable (1011-9000-000); ANAP01070, Not Applicable (1011-9000-000); 5473409-1, Not Applicable (2097674-FR); 5473409-2, Not Applicable (2097674-FR); 5473409-3, Not Applicable (2097674-FR); ANAP00517, Not Applicable (1011-9000-000); ANAP00518, Not Applicable (1011-9000-000); ANAP00519, Not Applicable (1011-9000-000); ANAM01291, Not Applicable (1011-9000-000); ANAM01292, Not Applicable (1011-9000-000); ANAM01293, Not Applicable (1011-9000-000); ANAN00430, Not Applicable (1011-9000-000); ANAN00431, Not Applicable (1011-9000-000); ANAN00432, Not Applicable (1011-9000-000); ANAN00436, Not Applicable (1011-9000-000); ANAN00437, Not Applicable (1011-9000-000); ANAP00300, Not Applicable (1011-9000-000); ANAQ00766, Not Applicable (1011-9000-000); ANAS00753, Not Applicable (1011-9000-000); ANAP00492, Not Applicable (1011-9000-000); ANAP00493, Not Applicable (1011-9000-000); ANAM00628, Not Applicable (1011-9000-000); ANAL01029, Not Applicable (1011-9000-000); 5479515-1, Not Applicable (2097674-JA); 5479515-2, Not Applicable (2097674-JA); 5479515-3, Not Applicable (2097674-JA); 5479515-4, Not Applicable (2097674-JA); 5479515-5, Not Applicable (2097674-JA); 5479515-6, Not Applicable (2097674-JA); 5479515-7, Not Applicable (2097674-JA); 5479515-8, Not Applicable (2097674-JA); 5479515-9, Not Applicable (2097674-JA); 5480673-1, Not Applicable (2097674-JA); 5480673-2, Not Applicable (2097674-JA); 5480673-3, Not Applicable (2097674-JA); 5480673-4, Not Applicable (2097674-JA); 5480673-5, Not Applicable (2097674-JA); 5480673-6, Not Applicable (2097674-JA); 5480673-7, Not Applicable (2097674-JA); 5480673-8, Not Applicable (2097674-JA); 5483069-1, Not Applicable (2097674-JA); ANAQ01435, Not Applicable (1011-9000-000); ANAM01312, Not Applicable (1011-9000-000); ANAM01313, Not Applicable (1011-9000-000); ANAM01315, Not Applicable (1011-9000-000); ANAM01317, Not Applicable (1011-9000-000); ANAM01318, Not Applicable (1011-9000-000); ANAM01320, Not Applicable (1011-9000-000); ANAM01324, Not Applicable (1011-9000-000); ANAM01325, Not Applicable (1011-9000-000); ANAL01313, Not Applicable (1011-9000-000); ANAL01314, Not Applicable (1011-9000-000); ANAL01315, Not Applicable…
Recall started: Sept. 27, 2018
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Software design
What the company told customers: GE Healthcare notified customers on about 09/27/2018 via "URGENT MEDICAL DEVICE CORRECTION" letter. The letter informed customers that they could continue to use the anesthesia device. The issue can only occur if the patient stops spontaneous breathing in PSVPro ventilation mode after completion of lung recruitment breaths. Stopping the Cycling Procedure resolves the issue. Continue to monitor patient as is normal for Apnea. A GE Healthcare representative will contact each customer to arrange for the correction. Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0411-2019

Aisys CS2 Anesthesia System…

Product: Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
Quantity: 4,207 units total
Codes and lots: Model Number, UDI Number, (Serial Number): 1011-9050-000, 010084068210229221APWX0132811180608, (APWX01328); 1011-9050-000, 010084068210229221APWX0048411180208, (APWX00484); 1011-9050-000, 010084068210229221APWW0214911171214, (APWW02149); 1011-9050-000, 10084068210229221APWW0215011171214, (APWW02150); 1011-9050-000, 010084068210229221APWX0026111180118, (APWX00261); 1011-9050-000, 010084068210229221APWX0026211180118, (APWX00262); 1011-9050-000, 010084068210229221APWX0140911180618, (APWX01409); 1011-9050-000, 010084068210229221APWX0141011180618, (APWX01410); 1011-9050-000, 010084068210229221APWX0141111180618, (APWX01411); 1011-9050-000, 010084068210229221APWX0141211180618, (APWX01412); 1011-9050-000, 010084068210229221APWX0141311180618, (APWX01413); 1011-9050-000, 010084068210229221APWX0141411180618, (APWX01414); 1011-9050-000, 010084068210229221APWX0141511180618, (APWX01415); 1011-9050-000, 010084068210229221APWX0141611180618, (APWX01416); 1011-9050-000, 010084068210229221APWX0141711180618, (APWX01417); 1011-9050-000, 010084068210229221APWX0141811180618, (APWX01418); 1011-9050-000, 010084068210229221APWX0141911180618, (APWX01419); 1011-9050-000, 010084068210229221APWX0142011180618, (APWX01420); 1011-9050-000, 010084068210229221APWX0142111180618, (APWX01421); 1011-9050-000, 010084068210229221APWX0142211180618, (APWX01422); 1011-9050-000, 010084068210229221APWX0026311180118, (APWX00263); 1011-9050-000, 010084068210229221APWX0026411180118, (APWX00264); 1011-9050-000, 010084068210229221APWX0026511180118, (APWX00265); 1011-9050-000, 010084068210229221APWW0214011171214, (APWW02140); 1011-9050-000, 010084068210229221APWW0215611171214, (APWW02156); 1011-9050-000, 010084068210229221APWW0215711171214, (APWW02157); 1011-9050-000, 010084068210229221APWX0158911180703, (APWX01589); 1011-9050-000, 010084068210229221APWX0159011180703, (APWX01590); 1011-9050-000, 010084068210229221APWX0159111180703, (APWX01591); 1011-9050-000, 010084068210229221APWX0159211180703, (APWX01592); 1011-9050-000, 010084068210229221APWX0159311180703, (APWX01593); 1011-9050-000, 010084068210229221APWX0159411180703, (APWX01594); 1011-9050-000, 010084068210229221APWW0146411170823, (APWW01464); 1011-9050-000, 10084068210229221APWW0162511170927, (APWW01625); 1011-9050-000, 10084068210229221APWW0162611170927, (APWW01626); 1011-9050-000, 10084068210229221APWW0162811170927, (APWW01628); 1011-9050-000, 10084068210229221APWW0208811171206, (APWW02088); 1011-9050-000, 10084068210229221APWW0208911171206, (APWW02089); 1011-9050-000, 10084068210229221APWW0209011171206, (APWW02090); 1011-9050-000, 10084068210229221APWW0209111171212, (APWW02091); 1011-9050-000, 10084068210229221APWW0209211171212, (APWW02092); 1011-9050-000, 10084068210229221APWW0209311171212, (APWW02093); 1011-9050-000, 10084068210229221APWW0209411171212, (APWW02094); 1011-9050-000, 10084068210229221APWW0209511171212, (APWW02095); 1011-9050-000, 10084068210229221APWW0209611171212, (APWW02096); 1011-9050-000, 10084068210229221APWW0209711171212, (APWW02097); 1011-9050-000, 10084068210229221APWW0209811171212, (APWW02098); 1011-9050-000, 10084068210229221APWW0209911171212, (APWW02099); 1011-9050-000, 10084068210229221APWW0210011171212, (APWW02100); 1011-9050-000, 10084068210229221APWW0210111171212, (APWW02101); 1011-9050-000, 10084068210229221APWW0210211171212, (APWW02102); 1011-9050-000, 10084068210229221APWW0210311171212, (APWW02103); 1011-9050-000, 010084068210229221APWX0086711180328, (APWX00867); 1011-9050-000, 010084068210229221APWX0086811180328, (APWX00868); 1011-9050-000, 010084068210229221APWX0086911180328, (APWX00869); 1011-9050-000, 010084068210229221APWX0087011180328, (APWX00870); 1011-9050-000, 010084068210229221APWX0087111180328, (APWX00871); 1011-9050-000, 010084068210229221APWX0087211180328, (APWX00872); 1011-9050-000, 010084068210229221APWX0036911180131, (APWX00369); 1011-9050-000, 010084068210229221APWX0143411180618, (APWX01434); 1011-9050-000, 010084068210229221APWX0143511180618, (APWX01435); 1011-9050-000, 010084068210229221APWX0105311180427, (APWX01053); 1011-9050-000, 010084068210229221APWX0165911180716, (APWX01659); 1011-9050-000, 010084068210229221APWX0166011180716, (APWX01660); 1011-9050-000, 010084068210229221APWX0166111180716, (APWX01661); 1011-9050-000, 010084068210229221APWX0166211180716, (APWX01662); 1011-9050-000, 010084068210229221APWX0166311180716, (APWX01663); 1011-9050-000, 010084068210229221APWX0166411180716, (APWX01664); 1011-9050-000, 010084068210229221APWX0166511180716, (APWX01665); 1011-9050-000, 010084068210229221APWX0166611180716, (APWX01666); 2097675-001-US, Not Applicable, (4651698-2); 2097675-001-US, Not Applicable, (4666280-1); 2097675-001-US, Not Applicable, (4666282-1); 2097675-001-US, Not Applicable, (4666283-1); 2097675-001-US, Not Applicable, (4666288-1); 2097675-001-US, Not Applicable, (4666291-1); 2097675-001-US, Not Applicable, (4666300-1); 2097675-001-US, Not Applicable, (4666308-1); 2097675-001-US, Not Applicable, (4666314-1); 2097675-001-US, Not Applicable, (4666324-1); 2097675-001-US, Not Applicable, (4666335-1); 2097675-001-US, Not Applicable, (4666567-1); 1011-9050-000, 010084068210229221APWX0067511180315, (APWX00675); 1011-9050-000, 010084068210229221APWX0102611180417, (APWX01026); 1011-9050-000, 010084068210229221APWW0221511171219, (APWW02215); 1011-9050-000, 10084068210229221APWW0221611171219, (APWW02216); 1011-9050-000, 10084068210229221APWW0221711171219, (APWW02217); 1011-9050-000, 10084068210229221APWW0221811171219, (APWW02218); 1011-9050-000, 10084068210229221APWW0221911171219, (APWW02219); 1011-9050-000, 10084068210229221APWW0222011171219, (APWW02220); 1011-9050-000, 10084068210229221APWW0222111171219, (APWW02221); 1011-9050-000, 10084068210229221APWW0222211171219, (APWW02222); 1011-9050-000, 10084068210229221APWW0222311171219, (APWW02223); 1011-9050-000, 10084068210229221APWW0222411171219, (APWW02224); 1011-9050-000, 10084068210229221APWW0222511171219, (APWW02225); 1011-9050-000, 10084068210229221APWW0222611171219, (APWW02226); 1011-9050-000, 10084068210229221APWW0222711171219, (APWW02227); 1011-9050-000, 10084068210229221APWW0222811171219, (APWW02228); 1011-9050-000, 10084068210229221APWW0222911171219, (APWW02229); 1011-9050-000, 10084068210229221APWW0223011171219, (APWW02230); 1011-9050-000, 010084068210229221APWX0112211180507, (APWX01122); 1011-9050-000, 010084068210229221APWX0155711180627, (APWX01557); 1011-9050-000, 010084068210229221APWX0014411180105, (APWX00144); 1011-9050-000, 010084068210229221APWW0215111171214, (APWW02151); 1011-9050-000, 010084068210229221APWX0043411180206, (APWX00434); 1011-9050-000, 010084068210229221APWX0038711180201, (APWX00387); 1011-9050-000, 010084068210229221APWX0038811180201, (APWX00388); 1011-9050-000, 010084068210229221APWX0038911180201, (APWX00389); 1011-9050-000, 010084068210229221APWX0039011180201, (APWX00390); 1011-9050-000, 010084068210229221APWX0039111180201, (APWX00391); 1011-9050-000, 010084068210229221APWX0039211180201, (APWX00392); 1011-9050-000, 010084068210229221APWX0039311180201, (APWX00393); 1011-9050-000, 010084068210229221APWW0212811171212, (APWW02128); 1011-9050-000, 010084068210229221APWW0212911171212, (APWW02129); 1011-9050-000, 010084068210229221APWW0213011171212, (APWW02130); 1011-9050-000, 10084068210229221APWW0213111171214, (APWW02131); 1011-9050-000, 10084068210229221APWW0213211171214, (APWW02132); 1011-9050-000, 10084068210229221APWW0213311171214, (APWW02133); 1011-9050-000, 010084068210229221APWW0213411171214, (APWW02134); 1011-9050-000, 010084068210229221APWW0213511171214, (APWW02135); 1011-9050-000, 010084068210229221APWW0213611171214, (APWW02136); 1011-9050-000, 010084068210229221APWX0104411180427, (APWX01044); 1011-9050-000, 010084068210229221APWX0078811180323, (APWX00788); 1011-9050-000, 010084068210229221APWX0078911180323, (APWX00789); 1011-9050-000, 010084068210229221APWX0079011180323, (APWX00790); 1011-9050-000, 010084068210229221APWX0079111180328, (APWX00791); 1011-9050-000, 010084068210229221APWX0079211180328, (APWX00792); 1011-9050-000, 010084068210229221APWX0079311180328, (APWX00793); 1011-9050-000, 010084068210229221APWX0079411180328, (APWX00794); 1011-9050-000, 010084068210229221APWX0079511180328, (APWX00795); 1011-9050-000, 010084068210229221APWX0079611180328, (APWX00796); 1011-9050-000, 010084068210229221APWX0079711180328, (APWX00797); 1011-9050-000, 010084068210229221APWX0079811180328, (APWX00798); 1011-9050-000, 010084068210229221APWX0079911180328, (APWX00799); 1011-9050-000, 010084068210229221APWX0080011180328, (APWX00800); 1011-9050-000, 010084068210229221APWX0080111180328, (APWX00801); 1011-9050-000, 010084068210229221APWX0080211180328, (APWX00802); 1011-9050-000, 010084068210229221APWX0080311180328, (APWX00803); 1011-9050-000, 010084068210229221APWX0080411180328, (APWX00804); 1011-9050-000, 010084068210229221APWX0080511180328, (APWX00805); 1011-9050-000, 010084068210229221APWX0080611180328, (APWX00806); 1011-9050-000, 010084068210229221APWX0080711180328, (APWX00807); 1011-9050-000, 010084068210229221APWX0080811180328, (APWX00808); 1011-9050-000, 010084068210229221APWX0080911180328, (APWX00809); 1011-9050-000, 010084068210229221APWX0162811180711, (APWX01628); 1011-9050-000, 010084068210229221APWX0021611180115, (APWX00216); 1011-9050-000, 010084068210229221APWX0132311180608, (APWX01323); 1011-9050-000, 010084068210229221APWX0132411180608, (APWX01324); 1011-9050-000, 010084068210229221APWW0137311170802, (APWW01373); 1011-9050-000, 010084068210229221APWX0064811180309, (APWX00648); 1011-9050-000, 010084068210229221APWX0106011180427, (APWX01060); 1011-9050-000, 010084068210229221APWX0106111180427, (APWX01061); 1011-9050-000, 010084068210229221APWX0106211180427, (APWX01062); 1011-9050-000, 010084068210229221APWX0106311180427, (APWX01063); 1011-9050-000, 010084068210229221APWW0214111171214, (APWW02141); 1011-9050-000, 010084068210229221APWW0223111171219, (APWW02231); 1011-9050-000, 010084068210229221APWX0066111180309, (APWX00661); 1011-9050-000, 010084068210229221APWX0066211180309, (APWX00662); 1011-9050-000, 010084068210229221APWX0066311180309, (APWX00663); 1011-9050-000, 010084068210229221APWX0066411180309, (APWX00664); 1011-9050-000, 010084068210229221APWX0066511180309, (APWX00665); 1011-9050-000, 010084068210229221APWX0066611180309, (APWX00666); 1011-9050-000, 010084068210229221APWX0066711180309, (APWX00667); 1011-9050-000, 010084068210229221APWX0066811180309, (APWX00668); 1011-9050-000, 010084068210229221APWX0066911180309, (APWX00669); 1011-9050-000, 010084068210229221APWX0067011180309, (APWX00670); 1011-9050-000, 010084068210229221APWX0067111180315, (APWX00671); 1011-9050-000, 010084068210229221APWX0067211180315, (APWX00672); 1011-9050-000, 010084068210229221APWX0067311180315, (APWX00673); 1011-9050-000, 010084068210229221APWX0067611180315, (APWX00676); 1011-9050-000, 010084068210229221APWX0067711180315, (APWX00677); 1011-9050-000, 010084068210229221APWX0067811180315, (APWX00678); 1011-9050-000, 010084068210229221APWX0067911180315, (APWX00679); 1011-9050-000, 010084068210229221APWX0068011180315, (APWX00680); 1011-9050-000, 010084068210229221APWX0068111180315, (APWX00681); 1011-9050-000, 010084068210229221APWX0068211180315, (APWX00682); 1011-9050-000, 010084068210229221APWX0068311180315, (APWX00683); 1011-9050-000, 010084068210229221APWX0068411180315, (APWX00684); 1011-9050-000, 010084068210229221APWX0068511180315, (APWX00685); 1011-9050-000, 010084068210229221APWX0068611180315, (APWX00686); 1011-9050-000, 010084068210229221APWX0068711180315, (APWX00687); 1011-9050-000, 010084068210229221APWX0069111180315, (APWX00691); 1011-9050-000, 010084068210229221APWX0069211180315, (APWX00692); 1011-9050-000, 010084068210229221APWX0069311180315, (APWX00693); 1011-9050-000, 010084068210229221APWX0069411180315, (APWX00694); 1011-9050-000, 010084068210229221APWX0069511180315, (APWX00695); 1011-9050-000, 010084068210229221APWX0069611180315, (APWX00696); 1011-9050-000, 010084068210229221APWX0069711180315, (APWX00697); 1011-9050-000…
Recall started: Sept. 27, 2018
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Software design
What the company told customers: GE Healthcare notified customers on about 09/27/2018 via "URGENT MEDICAL DEVICE CORRECTION" letter. The letter informed customers that they could continue to use the anesthesia device. The issue can only occur if the patient stops spontaneous breathing in PSVPro ventilation mode after completion of lung recruitment breaths. Stopping the Cycling Procedure resolves the issue. Continue to monitor patient as is normal for Apnea. A GE Healthcare representative will contact each customer to arrange for the correction. Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0412-2019

Touchscreen display kit…

Product: Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN DISPLAY KIT 11.X DANISH, TOUCHSCREEN DISPLAY KIT 11.X ESTONIAN, TOUCHSCREEN DISPLAY KIT 11.X ITALIAN, TOUCHSCREEN DISPLAY KIT 11.X NORWEGIAN. Product Usage: The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
Quantity: 4,207 units total
Codes and lots: Model Number, UDI Number, (Serial Number): 2097673-001-US (4651698-1); 2097673-001-US (4651698-3); 2097673-001-US (4651698-4); 2097673-001-US (4651726-1); 2097673-001-US (4652206-1); 2097673-001-US (4652206-2); 2097673-001-US (4649618-1); 2097673-001-US (4649618-2); 2097673-001-US (4649618-3); 2097673-001-US (4649618-4); 2097673-001-US (4649618-5); 2097673-001-US (4653227-1); 2097673-001-US (4653227-2); 2097673-001-US (4653227-3); 2097673-001-US (5474296-1); 2097673-001-US (4652587-1); 2097673-001-US (4652587-2); 2097673-001-US (4652587-3); 2097673-001-US (4652587-4); 2097673-001-US (4652587-5); 2097673-001-US (4652587-6); 2097673-001-US (4632861-1); 2097673-001-US (4632861-2); 2097673-001-US (4632861-3); 2097673-001-US (4644953-1); 2097673-001 (5463757-1); 2097673-001 (5467309-16); 2097673-001 (5471699-1); 2097673-001 (5471699-2); 2097673-001 (5471699-3); 2097673-001 (5475515-1); 2097673-001 (5475515-2); 2097673-001 (5475516-1); 2097673-001 (5475516-10); 2097673-001 (5475516-2); 2097673-001 (5475516-3); 2097673-001 (5475516-4); 2097673-001 (5475516-5); 2097673-001 (5475516-6); 2097673-001 (5475516-7); 2097673-001 (5475516-8); 2097673-001 (5475516-9); 2097673-001 (5475528-1); 2097673-001 (5475528-10); 2097673-001 (5475528-11); 2097673-001 (5475528-12); 2097673-001 (5475528-13); 2097673-001 (5475528-14); 2097673-001 (5475528-15); 2097673-001 (5475528-16); 2097673-001 (5475528-17); 2097673-001 (5475528-18); 097673-001 (5475528-19); 2097673-001 (5475528-2); 2097673-001 (5475528-3); 2097673-001 (5475528-4); 2097673-001 (5475528-5); 2097673-001 (5475528-6); 2097673-001 (5475528-7); 2097673-001 (5475528-8); 2097673-001 (5475528-9); 2097673-001 (5481650-1); 2097673-001 (5481650-10); 2097673-001 (5481650-2); 2097673-001 (5481650-3); 097673-001 (5481650-4); 2097673-001 (5481650-5); 2097673-001 (5481650-6); 2097673-001 (5481650-7); 2097673-001 (5481650-8); 2097673-001 (5481650-9); 2097673-001 (5471701-1); 2097673-001 (5471701-2); 2097673-001 (5471702-1); 2097673-001 (5472013-1); 2097673-001 (5472013-10); 097673-001 (5472013-12); 2097673-001 (5472013-14); 2097673-001 (5472013-15); 2097673-001 (5472013-16); 2097673-001 (5472013-17); 2097673-001 (5472013-18); 2097673-001 (5472013-3); 2097673-001 (5472013-4); 2097673-001 (5472013-5); 2097673-001 (5472013-6); 2097673-001 (5472013-7); 2097673-001 (5472013-8); 2097673-001 (5463631-1); 2097673-001 (5463631-2); 2097673-001 (5466892-1); 2097673-001 (5466892-10); 2097673-001 (5466892-2); 2097673-001 (5466892-3); 2097673-001 (5466892-4); 2097673-001 (5466892-5); 2097673-001 (5466892-6); 2097673-001 (5466892-7); 2097673-001 (5466892-8); 2097673-001 (5466892-9); 2097673-DE (5480919-1); 2097673-NL (5473301-1); 2097673-NL (5473301-2); 2097673-NL (5473301-3); 2097673-NL (5473301-4); 2097673-NL (5473301-5); 2097673-NL (5473301-6); 2097673-FR (5481162-1); 2097673-NL (5481369-1); 2097673-NL (5481369-2); 2097673-NL (5481369-3); 2097673-NL (5481369-4); 2097673-NL (5481369-5); 2097673-NL (5481369-6); 2097673-NL (5481369-7); 2097673-NL (5481369-8); 2097673-NL (5481369-9); 2097673-001 (5462738-1); 2097673-001 (5462738-2); 2097673-FR (5475371-1); 2097673-FR (5475371-2); 2097673-FR (5475371-3); 2097673-FR (5475371-4); 2097673-FR (5475371-5); 2097673-FR (5479900-1); 2097673-DA (5453900-1); 2097673-ET (5461749-1); 2097673-FR (5481462-1); 2097673-FR (5481462-2); 2097673-FR (5481462-3); 2097673-FR (5481462-4); 2097673-FR (5481462-5); 2097673-FR (5481462-6); 2097673-FR (5481462-7); 2097673-FR (5481462-8); 2097673-FR (5481462-9); 2097673-FR (5473743-1); 2097673-FR (5473743-2); 2097673-FR (5473743-3); 2097673-FR (5473743-4); 2097673-FR (5473743-5); 2097673-FR (5473744-1); 2097673-FR (5473744-2); 2097673-FR (5473744-3); 2097673-FR (5473744-4); 2097673-FR (5473744-5); 2097673-FR (5473744-6); 2097673-FR (5458277-1); 2097673-FR (5458277-2); 2097673-001 (5455478-1); 2097673-IT (5476554-1); 2097673-IT (5476554-2); 2097673-IT (5476554-3); 2097673-NL (5450447-1); 2097673-NL (5450447-3); 2097673-NL (5450447-5); 2097673-NL (5450447-6); 2097673-NO (5474251-1); 2097673-001 (5476468-70); 2097673-001 (5476468-71); 2097673-001 (5476468-72); 2097673-001 (5476468-73); 2097673-001 (5476468-74); 2097673-001 (5476468-75); 2097673-001 (5476468-76); 2097673-001 (5476468-77); 2097673-001 (5476468-78); 2097673-001 (5476468-79); 2097673-001 (5476468-80); 2097673-001 (5476468-81); 2097673-001 (5476468-82); 2097673-001 (5476468-83); 2097673-001 (5476468-84); 2097673-001 (5476468-85); 2097673-001 (5476468-86); 2097673-001-US (4673852-1); 2097673-001-US (4673852-2); 2097673-001-US (4673852-3); Additional Serial Numbers - Model Number, UDI Number, (Serial Number): 2097673-001-US, Not Applicable, (ANAM00306); 2097673-001-US, Not Applicable, (ANAP00354); 2097673-001-US, Not Applicable, (APWU00297); 2097673-001-US, Not Applicable, (ANAP00715); 2097673-001-US, Not Applicable, (ANAR00602); 2097673-001-US, Not Applicable, (ANAR00603); 2097673-001-US, Not Applicable, (ANAN00169); 2097673-001-US, Not Applicable, (ANAP00574); 2097673-001-US, Not Applicable, (ANAP00575); 2097673-001-US, Not Applicable, (ANAP00576); 2097673-001-US, Not Applicable, (ANAP00577); 2097673-001-US, Not Applicable, (ANAQ01175); 2097673-001-US, Not Applicable, (ANAP00172); 2097673-001-US, Not Applicable, (ANAP00861); 2097673-001-US, Not Applicable, (ANAP00870); 2097673-001-US, Not Applicable, (ANAP00872); 2097673-001-US, Not Applicable, (ANAS00398 ); 2097673-001-US, Not Applicable, (ANAL00105); 2097673-001-US, Not Applicable, (ANAL00106); 2097673-001-US, Not Applicable, (ANAL00107); 2097673-001-US, Not Applicable, (ANAL00108); 2097673-001-US, Not Applicable, (ANAL00109); 2097673-001-US, Not Applicable, (ANAL00116); 2097673-001-US, Not Applicable, (ANAM00439); 2097673-001-US, Not Applicable, (ANAM00440); 2097673-001-US, Not Applicable, (ANAM00441); 2097673-001-US, Not Applicable, (ANAP01088); 2097673-001-US, Not Applicable, (ANAP01090); 2097673-001-US, Not Applicable, (ANAP01091); 2097673-001, Not Applicable, (ANAN00604); 2097673-001, Not Applicable, (ANAM01165); 2097673-001, Not Applicable, (ANAM01158); 2097673-001, Not Applicable, (ANAM00815); 2097673-001, Not Applicable, (ANAM00816); 2097673-001, Not Applicable, (ANAM00817); 2097673-001, Not Applicable, (ANAM00818); 2097673-001, Not Applicable, (ANAM00819); 2097673-001, Not Applicable, (ANAM00820); 2097673-001, Not Applicable, (ANAM00821); 2097673-001, Not Applicable, (ANAM00822); 2097673-001, Not Applicable, (ANAM00823); 2097673-001, Not Applicable, (ANAM00824); 2097673-DE, Not Applicable, (ANAP01156); 2097673-001, Not Applicable, (ANAR00318); 2097673-001, Not Applicable, (ANAR00319); 2097673-FR, Not Applicable, (ANAR05232); 2097673-FR, Not Applicable, (ANAR05233); 2097673-FR, Not Applicable, (ANAR05234); 2097673-FR, Not Applicable, (ANAR05235); 2097673-FR, Not Applicable, (ANAR05236); 2097673-FR, Not Applicable, (ANAP01419); 1011-9000-000, Not Applicable, (APWT00661); 1011-9000-000, Not Applicable, (APWT00662); 1011-9000-000, Not Applicable, (APWT00664); 1011-9000-000, Not Applicable, (ANAN00664); 1011-9000-000, Not Applicable, (ANAN00666); 1011-9000-000, Not Applicable, (ANAN00667); 1011-9000-000, Not Applicable, (ANAN00669); 1011-9000-000, Not Applicable, (ANAN00670); 1011-9000-000, Not Applicable, (ANAN00671); 1011-9000-000, Not Applicable, (ANAN00890); 1011-9000-000, Not Applicable, (ANAN00891); 1011-9000-000, Not Applicable, (ANAR00396); 1011-9000-000, Not Applicable, (APWT02012); 1011-9000-000, Not Applicable, (APWT02013); 1011-9000-000, Not Applicable, (ANAN01101); 1011-9000-000, Not Applicable, (ANAP00605); 2097673-FR, Not Applicable, (ANAQ00803); 2097673-FR, Not Applicable, (ANAQ00806); 2097673-FR, Not Applicable, (ANAQ00948); 2097673-FR, Not Applicable, (ANAR05145); 2097673-FR, Not Applicable, (ANAR05150); 2097673-FR, Not Applicable, (ANAR05513); 2097673-FR, Not Applicable, (ANAR05517); 2097673-FR, Not Applicable, (ANAS00665); 2097673-FR, Not Applicable, (ANAS00666); 2097673-FR, Not Applicable, (ANAS00668); 2097673-FR, Not Applicable, (ANAS00971); 2097673-NO, Not Applicable, (ANAQ01098);
Recall started: Sept. 27, 2018
Device type: Gas-Machine, Anesthesia
Root cause (FDA): Software design
What the company told customers: GE Healthcare notified customers on about 09/27/2018 via "URGENT MEDICAL DEVICE CORRECTION" letter. The letter informed customers that they could continue to use the anesthesia device. The issue can only occur if the patient stops spontaneous breathing in PSVPro ventilation mode after completion of lung recruitment breaths. Stopping the Cycling Procedure resolves the issue. Continue to monitor patient as is normal for Apnea. A GE Healthcare representative will contact each customer to arrange for the correction. Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-0413-2019

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0411-2019, Z-0412-2019, Z-0413-2019. The agency record governs; check it and the company before acting.

Report a mistake on this page