GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray recall: Software Issue
GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
Why was GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray recalled?
GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US Code of Federal Regulations (21CFR) and IEC 60601-1-3.
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?
Model Number : 5271997
- Product
- GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 9 units installed in US
- Distribution
- Nationwide Distribution including NM, WY, FL, MO, MA, and MI.
- Recall date
- March 6, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)