Z-0240-2022 Class II Ongoing
FDA device recall Z-0240-2022 was initiated by Philips Healthcare on September 22, 2021 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 281 in total.
Recall Details
- Product Type
- Devices
- Report Date
- December 1, 2021
- Initiation Date
- September 22, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 281 in total
Product Description
ProxiDiagnost N90 is multi-functional general R/F systems.
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution
Code Information
ProxiDiagnost N90