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NA GM60A-40SRecalls & reported problems

Samsung Electronics Co., Ltd. · The GM60A-40S Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. 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
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 (K150097); 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. Jul 8, 2024Open, Classified

    Potential for the anti-fall system of the device arm to fail.

    Z-2715-2024 · Root cause: Device Design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150097. One submission often covers many models, so check the product and lot details in each record.

  • Z-0263-2016 · Sep 14, 2015 · Terminated
    Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.

Other System, X-Ray, Mobile devices

All System, X-Ray, Mobile devices →

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