DuraDiagnostRecalls & reported problems across all models
Philips Healthcare (Suzhou) Co., Ltd. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one DuraDiagnost model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 2 models of DuraDiagnost by Philips Healthcare (Suzhou) Co., Ltd. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Feb 21, 2023 and Feb 21, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Fell” (1 report).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
DuraDiagnost recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 10, 2025Open, Classified
Potential for collimator to fall as a result of incorrect installation.
Z-1554-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 10, 2025Open, Classified
Potential for collimator to fall as a result of incorrect installation.
Z-1553-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported DuraDiagnost problems
Device problems
- Device Fell1
- Device Handling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
DuraDiagnost models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DuraDiagnostSolid state x-ray imager (flat panel/digital imager)1 recall1 report
- DuraDiagnostSystem, x-ray, stationary1 recall0 reports
Recent DuraDiagnost adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2023Device Handling Problem; Device Fell; Device Handling Problem; Device Fell
THE CUSTOMER REPORTED THAT A PATIENT THREW THE DETECTOR AND THEY WANT TO FIND OUT IF THERE IS ANYTHING WRONG WITH IT. NO PATIENT OR USER HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16406474 ↗
Other Philips Healthcare (Suzhou) Co., Ltd. products
All Philips Healthcare (Suzhou) Co., Ltd. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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