FDA · Medical device recall

Innova IGS 630… and 2 more products

April 24, 2019 Class II

Date: April 24, 2019
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: Ongoing
Filed by: GE Healthcare, LLC
Reason: There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal simultaneously.
Distribution pattern: Nationwide distribution to AR, CA, CA, FL, MI, NM, NV, SC, TN, TX, VA, WA, WI. International distribution to Algeria, Belgium, China, Colombia, France, Hungary, Italy, Japan, Korea (Republic Of), Kuwait, Libya, Pakistan, Poland, Russia, Saudi Arabia, South Africa, Sudan, Turkey, Vietnam.

3 products in this recall

Innova IGS 630…

Product: Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Quantity: 1 device
Codes and lots: Model Number 5503558; System ID Number 0850060757; Serial Number B3-16-015
Recall started: March 15, 2019
Device type: System, X-Ray, Angiographic
Root cause (FDA): Device Design
What the company told customers: GE Healthcare notified customers on about 03/15/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customer were informed that they can continue to use their Innova IGS 6 or Innova IGS 630 Systems but must follow the following safety instructions: 1. Do not change the size of the field of view from 30cm to 20cm or 20cm to 30cm while releasing the fluoroscopy footswitch pedal. 2. Only perform these 2 actions sequentially. 3. If the system becomes locked up, perform a reset to recover functionalities. Customers were also informed that GE Healthcare will correct all affected products at no cost and a GE Healthcare representative will contact each customer to perform the correction. After the GE representative has updated the system, please destroy previous Innova IGS 6 SW package installation media related to this system (versions prior to IGS6_2.2.1 or IGS6_3.1.1). Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1199-2019

Innova IGS 630…

Product: Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Quantity: 49 devices
Codes and lots: Model Number 5730860; System ID (Serial Number, UDI Number): 352333VASC3 (B3-17-006, 01008406821086381117020021B3-17-006); 727869SPECIALS (B3-18-005, 01008406821086381118020021B3-18-005); 407518BIPLANE (B3-17-005, 01008406821086381117010021B3-17-005); 305227KBP630 (B3-16-017, 01008406821086381116080021B3-16-017); 401BIPLANE1 (B3-18-001, 01008406821086381118010021B3-18-001); 941629IGS630 (B3-18-002, 01008406821086381118010021B3-18-002); 505841CATH3 (B3-17-032, 01008406821086381117120021B3-17-032); 7022553131 (B3-17-011, 01008406821086381117030021B3-17-011); 7028803131 (B3-17-023, 01008406821086381117080021B3-17-023); 615769SP3 (B3-17-013, 01008406821086381117040021B3-17-013); 214618INIGS (B3-16-029, 01008406821086381116120021B3-16-029); 281890BP (B3-17-024, 01008406821086381117090021B3-17-024); 956632IGS630 (B3-17-029, 01008406821086381117120021B3-17-029); 804320IGS630 (B3-16-016, 01008406821086381116070021B3-16-016); DZ1009VA03 (B3-17-015, 01008406821086381117070021B3-17-015); 220826RX10 (B3-17-003, 01008406821086381117010021B3-17-003); 082416040099 (B3-19-001, 01008406821086381119020021B3-19-001); 082416160088 (B3-18-023, 01008406821086381118110021B3-18-023); 082416100170 (B3-19-003, 01008406821086381119020021B3-19-003); XV8624CO (B3-18-012, 01008406821086381118050021B3-18-012); N4192956 (B3-17-009, 01008406821086381117030021B3-17-009); A5820150 (B3-16-023, 01008406821086381116100021B3-16-023); YV1920 (B3-16-020, 01008406821086381116100021B3-16-020); YV1922 (B3-17-002, 01008406821086381117010021B3-17-002); YV1921 (B3-16-027, 01008406821086381116120021B3-16-027); YV4500 (B3-16-032, 01008406821086381117010021B3-16-032); YV4501 (B3-17-027, 01008406821086381117110021B3-17-027); YV2503 (B3-16-019, 01008406821086381116090021B3-16-019); YV4503 (B3-18-003, 01008406821086381118020021B3-18-003); YV4502 (B3-17-030, 01008406821086381117120021B3-17-030); 0850060758 (B3-17-014, 01008406821086381117070021B3-17-014); 0850060755 (B3-17-001, 01008406821086381117010021B3-17-001); 0850060759 (B3-18-013, 01008406821086381118060021B3-18-013); KW1008VA01 (B3-17-019, 01008406821086381117070021B3-17-019); KW1005VA02 (B3-16-025, 01008406821086381116110021B3-16-025); KW1005VA01 (B3-16-026, 01008406821086381116110021B3-16-026); LY1067VA01 (B3-17-010, 01008406821086381117030021B3-17-010); PK1003VA01 (B3-17-018, 01008406821086381117060021B3-17-018); RU2011VA02 (B3-17-004, 01008406821086381117010021B3-17-004); RU9774VA01 (B3-16-021, 01008406821086381116100021B3-16-021); SA2513VA01 (B3-16-024, 01008406821086381116100021B3-16-024); ZA2940VA01 (B3-17-025, 01008406821086381117100021B3-17-025); SD1084VA01 (B3-18-010, 01008406821086381118050021B3-18-010); 06189VAS06 (B3-17-028, 01008406821086381117110021B3-17-028); 55001VAS02 (B3-16-031, 01008406821086381116120021B3-16-031); 5973XR0085 (B3-17-007, 01008406821086381117020021B3-17-007); 5973XR0075 (B3-16-030, 01008406821086381116120021B3-16-030); 5973XR0076 (B3-17-008, 01008406821086381117030021B3-17-008); 5973XR0094 (B3-17-012, 01008406821086381117040021B3-17-012)
Recall started: March 15, 2019
Device type: System, X-Ray, Angiographic
Root cause (FDA): Device Design
What the company told customers: GE Healthcare notified customers on about 03/15/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customer were informed that they can continue to use their Innova IGS 6 or Innova IGS 630 Systems but must follow the following safety instructions: 1. Do not change the size of the field of view from 30cm to 20cm or 20cm to 30cm while releasing the fluoroscopy footswitch pedal. 2. Only perform these 2 actions sequentially. 3. If the system becomes locked up, perform a reset to recover functionalities. Customers were also informed that GE Healthcare will correct all affected products at no cost and a GE Healthcare representative will contact each customer to perform the correction. After the GE representative has updated the system, please destroy previous Innova IGS 6 SW package installation media related to this system (versions prior to IGS6_2.2.1 or IGS6_3.1.1). Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1200-2019

Innova IGS 6…

Product: Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Quantity: 22 devices
Codes and lots: Model Number 5771387; System ID (Serial Number, UDI Number): 501257IGS630 (B3-18-014, 01008406821246141118070021B3-18-014); 951486RU630 (B3-18-009, 01008406821246141118040021B3-18-009); 714993IGS630 (B3-18-004, 01008406821246141118020021B3-18-004); 906225EP1 (B3-18-015, 01008406821246141118070021B3-18-015); 906225CATH4 (B3-18-016, 01008406821246141118080021B3-18-016); 843797IGS30 (B3-18-030, 01008406821246141119010021B3-18-030); 4603984XV41 (B3-18-019, 01008406821246141118090021B3-18-019); MCARIGS630 (B3-18-008, 01008406821246141118040021B3-18-008); 509473RM1B (B3-18-028, 01008406821246141119010021B3-18-028); 414649IGS8 (B3-18-020, 01008406821246141118090021B3-18-020); HU1099VA07 (B3-18-024, 01008406821246141118110021B3-18-024); A670060221 (B3-19-002, 01008406821246141119020021B3-19-002); A5163326 (B3-18-007, 01008406821246141118030021B3-18-007); YV4504 (B3-18-018, 01008406821246141118090021B3-18-018); YV4505 (B3-18-027, 01008406821246141118120021B3-18-027); YV4507 (B3-18-022, 01008406821246141118110021B3-18-022); 0850060762 (B3-18-025, 01008406821246141118110021B3-18-025); 0850060763 (B3-18-026, 01008406821246141118120021B3-18-026); KW1155VA02 (B3-18-017, 01008406821246141118080021B3-18-017); PL1689VA01 (B3-18-021, 01008406821246141118100021B3-18-021); PL0302VA02 (B3-18-011, 01008406821246141118060021B3-18-011); 06189VAS11 (B3-18-029, 01008406821246141119010021B3-18-029)
Recall started: March 15, 2019
Device type: System, X-Ray, Angiographic
Root cause (FDA): Device Design
What the company told customers: GE Healthcare notified customers on about 03/15/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customer were informed that they can continue to use their Innova IGS 6 or Innova IGS 630 Systems but must follow the following safety instructions: 1. Do not change the size of the field of view from 30cm to 20cm or 20cm to 30cm while releasing the fluoroscopy footswitch pedal. 2. Only perform these 2 actions sequentially. 3. If the system becomes locked up, perform a reset to recover functionalities. Customers were also informed that GE Healthcare will correct all affected products at no cost and a GE Healthcare representative will contact each customer to perform the correction. After the GE representative has updated the system, please destroy previous Innova IGS 6 SW package installation media related to this system (versions prior to IGS6_2.2.1 or IGS6_3.1.1). Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Recall number: Z-1201-2019

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

Source: FDA · Medical device enforcement reports, recall numbers Z-1199-2019, Z-1200-2019, Z-1201-2019. The agency record governs; check it and the company before acting.

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