FDA · Medical device recall

GE Healthcare Optima IGS 320… and 12 more products

July 8, 2015 Class II

Date: July 8, 2015
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
Reason: GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova, Optima and Discovery).
Distribution pattern: Worldwide Distribution: US (nationwide) including states of: CA, DE, FL, GA, IL, IN, KS, MS, NV, OH, OK, OR, PA, TN, TX, VA, WA and WI; and countries of: ARGENTINA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, ITALY, JAPAN, RUSSIA, UNITED KINGDOM, and VIETNAM.

13 products in this recall

GE Healthcare Optima IGS 320…

Product: GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Quantity: 3
Codes and lots: System ID 083016208011415 5512XR0025 5512XR0033
Recall started: May 29, 2015
Device type: System, X-Ray, Angiographic
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1973-2015

GE Healthcare Discovery IGS 730…

Product: GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Quantity: 4
Codes and lots: Serial Number System ID 0000012C2A0003 214345IGS730 0000015A2A0012 AM137CZ18 0000015A2A0008 210060RX14 15A2A0011 GON4289057
Recall started: May 29, 2015
Device type: System, X-Ray, Angiographic
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1974-2015

GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740…

Product: GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Quantity: 3
Codes and lots: Serial Number System ID 15A2A0007 GON4109348 15A2A0013 740FMCD740 0000015A2A0009 355495XR01
Recall started: May 29, 2015
Device type: Interventional Fluoroscopic X-Ray System
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1975-2015

GE Healthcare Innova 2100IQ…

Product: GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Quantity: 13
Codes and lots: Serial Number System ID 00000465837BU3 610776INNOVA21 00000007C20214 760940INNOVA2 00000008C20031 083016842102488 00000007C20126 083016242100487 00000459677BU1 00888VAS02 0000011C2M0208 727869EP4 0000009C2M0034 083016608167379 0000009C2M0022 083016202100349 Not Available 0835160049 0000012C2S0028 A5403911 00000464565BU1 M2844529 0000011BC20026 2192632121 FMI12181DUMM17 082416270004 00000466838BU0 082416160007
Recall started: May 29, 2015
Device type: System, X-Ray, Angiographic
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1976-2015

GE Healthcare Innova 2121IQ…

Product: GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Quantity: 1
Codes and lots: Serial Number System ID 0000011BC20026 2192632121
Recall started: May 29, 2015
Device type: System, X-Ray, Angiographic
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1977-2015

GE Healthcare Innova 3100IQ…

Product: GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Quantity: 6
Codes and lots: Serial Number System ID 0000010C2M037O 620272INNOVA31 0000009C2M0192 X98766705 00000464106BU4 A5127281 00000007C20175 RU2741VA01 0000013C2S0087 082416100052 0000010C2M0299 082416100030
Recall started: May 29, 2015
Device type: System, X-Ray, Angiographic
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1978-2015

GE Healthcare Innova 3131IQ…

Product: GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Quantity: 2
Codes and lots: Serial Number System ID 005178429-0176 561881BP1 0000010BC20004 B5114298
Recall started: May 29, 2015
Device type: System, X-Ray, Angiographic
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1979-2015

GE Healthcare Innova IGS 520…

Product: GE Healthcare Innova IGS 520. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Quantity: 10
Codes and lots: Serial Number System ID 0000013C2S0065 302421IGS520 15C2R0058 LVIGS2 15C2R0065 AM1396F508 15C2R0082 206598UIGS 15C2R0092 AM135FE37 0000015C2R0062 HU1117VA01 0000015C2R0057 083016848125215 0000015C2R0069 5512XR0026 0000015C2R0060 00632VAS01 0000015C2R0080 00391VAS02
Recall started: May 29, 2015
Device type: System, X-Ray, Angiographic
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1980-2015

GE Healthcare Innova IGS 530…

Product: GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Quantity: 17
Codes and lots: Serial Number System ID Not Available 702731CATH3 0000013C2R0003 6012883100CV4 15C2R0084 702880CATH2 15C2R0086 GON4300165 15C2R0085 918787530 15C2R0087 814877EP 0000015C2R0091 GON1441141 0000014C2R0188 XV650620BU8 0000015C2R0083 GON1487269 0000015C2R0088 GON4271086 0000015C2R0064 080041RX18 15C2R0055 414649IGS2 15C2R0072 GON4211904 0000015C2R0074 0004077351 0000015C2R0066 082416190029 0000015C2R0070 082416100092 0000015C2R0071 082416190026
Recall started: May 29, 2015
Device type: System, X-Ray, Angiographic
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1981-2015

GE Healthcare Innova IGS 540…

Product: GE Healthcare Innova IGS 540. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Quantity: 6
Codes and lots: Serial Number System ID 0000012C2S0118 850862IGS 0000013C2S0207 352333VASC2 15C2R0063 GON4244211 15C2R0068 210297GE540 15C2R0053 804323IGS540 0000015C2R0059 0828160013
Recall started: May 29, 2015
Device type: System, X-Ray, Angiographic
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1982-2015

GE Healthcare Innova IGS 620…

Product: GE Healthcare Innova IGS 620. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Quantity: 3
Codes and lots: Serial Number System ID 00000657653BU2 509473RM12 657652BU4 503OHSUEP2 659961BU7 253426INNOVA5
Recall started: May 29, 2015
Device type: System, X-Ray, Angiographic
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1983-2015

GE Healthcare Innova IGS 630…

Product: GE Healthcare Innova IGS 630. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Quantity: 8
Codes and lots: Serial Number System ID 0000012CC20012 YV1950 00000641154BU0 YV1915 646036BU4 412647IR1 00000649367BU0 HCAALL630 00000656468BU6 5973XR0014 00000656469BU4 5973XR0013 657273BU9 936539CL5 Not Available 082416040067
Recall started: May 29, 2015
Device type: System, X-Ray, Angiographic
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1984-2015

GE Healthcare Optima CL 323i…

Product: GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
Quantity: 7
Codes and lots: Serial Number System ID Not Available GON4271838 Not Available 229890CL Not Available 361788CL323 Not Available 806358INNOVA 0C2V069A4104R1 082416310033 0C2V069A4202R1 082416200021 0C2V069A4203R1 082416050013
Recall started: May 29, 2015
Device type: System, X-Ray, Angiographic
Root cause (FDA): Nonconforming Material/Component
What the company told customers: The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter on 5/29/2015- GEHC Ref#12231- dated May 29, 2015 to their Consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction, and contact Information. The customers were instructed that you may continue to use the system and avoid rapid direction changes with the gantry motions and prevent potential collisions with other equipment. If the failure occurs during interventional examination, please ensure that you have established procedures for handling patients in case of the loss of gantry motion as stated in your product labeling. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for this correction. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1985-2015

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

Source: FDA · Medical device enforcement reports, recall numbers Z-1973-2015, Z-1974-2015, Z-1975-2015, Z-1976-2015, Z-1977-2015, Z-1978-2015, Z-1979-2015, Z-1980-2015 and others. The agency record governs; check it and the company before acting.

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