GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used recall: Labeling Error
GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
Why was GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used recalled?
mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).
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?
GE OEC Brivo 715 Prime Serial Numbers: B2S1301 6 B2S1301 8 B2S1302 1 B2S13022 B2S13025 B2S13039 B2S13060 B2S13063 B2S13065 B2S14001 B2S14007 B2S14022 B2S14039 B2S1404 0 B2S1404 5 B2S1406 5 B2S1406 6
- Product
- GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize.
- Recalling firm
- GE OEC Medical Systems, Inc
- Quantity
- 61 units installed in US
- Distribution
- Worldwide Distribution
- Recall date
- January 21, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)