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.
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling 49 Innova IGS 630 interventional fluoroscopic x-ray systems used to generate fluoroscopic and rotational images for cardiovascular, vascular, and non-vascular diagnostic procedures. The systems have a potential defect where the x-ray imaging function may be lost when a user simultaneously changes the field of view from 30cm to 20cm or from 20cm to 30cm while releasing the fluoroscopy footswitch pedal. The affected devices were distributed nationwide to twelve U.S. states and internationally to nineteen countries.
The recalled systems include multiple specific serial numbers and model variants identified in the recall notice. However, the source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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: 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. Quantity: 49 devices Lot/code info: 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, 01008
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.