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DuraDiagnost (REF 712214)Recalls & reported problems

Philips Healthcare (Suzhou) Co., Ltd. · The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications. · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838064751), 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).

1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Mar 10, 2025Open, Classified

    Potential for collimator to fall as a result of incorrect installation.

    Z-1554-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • Device Fell1
  • Device Handling Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, 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 Solid state x-ray imager (flat panel/digital imager) devices

All Solid state x-ray imager (flat panel/digital imager) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.