Skip to content

DuraDiagnost (REF 712203)Recalls & reported problems

Philips Healthcare (Suzhou) Co., Ltd. · Stationary x-ray system · Class 2

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

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K201640); they may or may not involve this specific model.

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-1553-2025 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201640. One submission often covers many models, so check the product and lot details in each record.

  • Z-1554-2025 · Mar 10, 2025 · Open, Classified
    Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.

Other System, x-ray, stationary devices

All System, x-ray, stationary devices →

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