FDAFDA · Food and drugs·Recall number Z-1974-2015
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.
Published July 8, 2015 · Recall initiated: May 29, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Healthcare
- Distributor
- 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.
- Lot
- Serial Number System ID 0000012C2A0003 214345IGS730 0000015A2A0012 AM137CZ18 0000015A2A0008 210060RX14 15A2A0011 GON4289057
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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