FDAFDA · Food and drugs·Recall number Z-1985-2015
GE Healthcare Optima CL 323i. 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 Not Available GON4271838 Not Available 229890CL Not Available 361788CL323 Not Available 806358INNOVA 0C2V069A4104R1 082416310033 0C2V069A4202R1 082416200021 0C2V069A4203R1 082416050013
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.