ProxiDiagnost N90 is multi-functional general R/F recall
ProxiDiagnost N90 is multi-functional general R/F systems.
Why was ProxiDiagnost N90 is multi-functional general R/F recalled?
The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control certification statement [21 CFR 1010.2]. Philips has determined that some systems at customer locations did not have these labels applied.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
ProxiDiagnost N90
- Product
- ProxiDiagnost N90 is multi-functional general R/F systems.
- Recalling firm
- Philips Healthcare
- Quantity
- 281 in total
- Distribution
- US Nationwide Distribution
- Recall date
- December 1, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)