GE Healthcare: 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 p

Is my product affected?

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.

• UPC 082416270004
• UPC 082416160007

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

What happened

GE Healthcare is recalling 13 Innova 2100IQ angiographic X-ray systems used worldwide to generate fluoroscopic and rotational diagnostic images. The systems may experience a loss of C-arm gantry motion capability, which is a potential safety issue affecting the imaging equipment's ability to function properly during interventional and image-guided surgical procedures.

The affected systems are distributed across the United States in multiple states and internationally in countries including Canada, China, France, Germany, India, Italy, Japan, Russia, and the United Kingdom, among others. The recall record does not specify a remedy or any required action for affected consumers.

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: 13 Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

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

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