CLASS II Device recall · Reported 3 Feb 2021 · FDA Enforcement Report
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system recalled
Philips Home Healthcare Solution is recalling ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system, distributed nationwide in the US. The recall was initiated on 8 Dec 2020 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-0727-2021
- FDA event ID
- 87039
- Recalling firm
- Philips Home Healthcare Solution, Cambridge, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Dec 2020
- FDA classified
- 31 Dec 2020
- Reported
- 3 Feb 2021
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 8 Dec 2020 | Recall initiated by company | |
| 31 Dec 2020 | Classified by FDA | +23 days |
| 3 Feb 2021 | Published in enforcement report | +34 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.
Product as listed by the FDA
ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command.
Which lots are affected?
Pending
Where was it sold?
Nationwide
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.
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