GE Healthcare: 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

Is my product affected?

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.

• UPC 082416040067

Check against the official notice below — it lists the full affected range.

What happened

GE Healthcare has recalled eight Innova IGS 630 angiographic X-ray systems used to generate fluoroscopic and rotational diagnostic images due to a potential safety issue that may cause loss of C-arm gantry motion capability. These systems were distributed worldwide, including to multiple states across the United States (California, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Mississippi, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, and Wisconsin) and to countries including Argentina, Belgium, Brazil, Canada, Chile, China, France, Germany, Hong Kong, Hungary, India, Indonesia, Italy, Japan, Russia, the United Kingdom, and Vietnam.

The affected systems are identified by specific serial numbers listed in the recall record. The source document does not specify what actions affected consumers or facilities should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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).

Details from the source

Reason for recall: 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: 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. Quantity: 8 Lot/code info: Serial Number System ID 0000012CC20012 YV1950 00000641154BU0 YV1915 646036BU4 412647IR1 00000649367BU0 HCAALL630 00000656468BU6 5973XR0014 00000656469BU4 5973XR0013 657273BU9 936539CL5 Not Available 082416040067

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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