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.
Take action
Contact the company
📍Recalling firmPHILIPS HOME HEALTHCARE SOLUTION222 Jacobs St · Cambridge, MA 02141-2289
“PHILIPS ProxiDiagnost N90 X-Ray System Recall: Incorrect Locking After Command.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63704-philips-proxidiagnost-n90-x-ray-system-recall-incorrect-locking-after. Based on FDA recall #Z-0727-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0727-2021%22&limit=1).
The Food and Drug Administration announced on Dec. 8, 2020, that Philips Home Healthcare Solution is recalling its ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system due to a potential hazard. The agency classified the recall as Class II and mandated.
How to tell if you have it
Brand: PHILIPS HOME HEALTHCARE SOLUTION
Product: ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
Quantity: 91 units
The hazard
According to the FDA, 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.
Context
GovInfoNow's records show Philips issued other recent recalls of similar products include Philips ALLURA Xper FD10 OR Table Recall (2026-03-03), Philips Xper FD20 X-ray System Recall (2026-03-03), and Philips Azurion 5 M12 X-ray System May Not Start Properly - Recall (2026-03-03).
How to tell if you have this one
The ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system is affected. No specific model numbers or dates are provided in the recall notice.
Brand
PHILIPS HOME HEALTHCARE SOLUTION
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Status
Verify if the device has the Lock-in command feature that may adjust settings after collimator shutter movement.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0727-2021 (December 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0727-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.