CLASS II ONGOING Device recall · Reported 1 Dec 2021 · FDA Enforcement Report
ProxiDiagnost N90 is multi-functional general R/F systems recalled
Philips Healthcare is recalling ProxiDiagnost N90 is multi-functional general R/F systems, distributed nationwide in the US. The recall was initiated on 22 Sep 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0240-2022
- FDA event ID
- 89023
- Recalling firm
- Philips Healthcare, Andover, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Sep 2021
- FDA classified
- 24 Nov 2021
- Reported
- 1 Dec 2021
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Sep 2021 | Recall initiated by company | |
| 24 Nov 2021 | Classified by FDA | +63 days |
| 1 Dec 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
ProxiDiagnost N90 is multi-functional general R/F systems.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it 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.
Which lots are affected?
ProxiDiagnost N90
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 89023This product is part of a recall event; the main page for the event is CombiDiagnost R90 is multi-functional general R/F systems recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | CombiDiagnost R90 is multi-functional general R/F systems recalled | Philips Healthcare | Other | Nationwide | |
| CLASS II | DigitalDiagnost C90 recalled by Philips Healthcare | Philips Healthcare | Other | Nationwide |
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