Azurion FlexArm recall
Azurion FlexArm, 722079
Why was Azurion FlexArm recalled?
During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.
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 numbers 637, 638
- Product
- Azurion FlexArm, 722079
- Recalling firm
- Philips North America, LLC
- Quantity
- 2
- Distribution
- Distributed to one account in Florida, and one international account in Germany.
- Recall date
- April 17, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)