GE Healthcare Innova IGS 540. Angiographic X-ray recall
GE Healthcare Innova IGS 540. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic…
Why was GE Healthcare Innova IGS 540. Angiographic X-ray recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Number System ID 0000012C2S0118 850862IGS 0000013C2S0207 352333VASC2 15C2R0063 GON4244211 15C2R0068 210297GE540 15C2R0053 804323IGS540 0000015C2R0059 0828160013
- Product
- GE Healthcare Innova IGS 540. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic…
- Recalling firm
- GE Healthcare
- Quantity
- 6
- 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.
- Recall date
- July 8, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)