FDA Device recall Z-0240-2022
ProxiDiagnost N90 is multi-functional general R/F systems
- FDA Device
- Class II
- ongoing
- Published 2021-12-01
On 2021-12-01 the FDA classified a Class II recall of ProxiDiagnost N90 is multi-functional general R/F systems by Philips Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0240-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-22 |
| Published | 2021-12-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips Healthcare |
| Distribution | US |
Product
ProxiDiagnost N90 is multi-functional general R/F systems.
Reason
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.
Identifiers
| code_info | ProxiDiagnost N90 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Philips Healthcare
- Incisive CT, software version 5.0
FDA Device · Class II · 2023-10-11 · Philips Healthcare - Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
FDA Device · Class II · 2022-04-13 · Philips Healthcare - Azurion systems with software release R2.0.x
FDA Device · Class II · 2022-03-30 · Philips Healthcare - CombiDiagnost R90 is multi-functional general R/F systems
FDA Device · Class II · 2021-12-01 · Philips Healthcare - Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
FDA Device · Class II · 2021-12-01 · Philips Healthcare
All Philips Healthcare recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0240-2022%22
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