GE Healthcare Innova 3100IQ. Angiographic X-ray systems recall
GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic…
Why was GE Healthcare Innova 3100IQ. Angiographic X-ray systems 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 0000010C2M037O 620272INNOVA31 0000009C2M0192 X98766705 00000464106BU4 A5127281 00000007C20175 RU2741VA01 0000013C2S0087 082416100052 0000010C2M0299 082416100030
- Product
- GE Healthcare Innova 3100IQ. 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)