NA GM60A-32SRecalls & reported problems
Samsung Electronics Co., Ltd. · The GM60A-32S 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
- 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 · TerminatedSamsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
Other Solid State X-Ray Imager (Flat Panel/Digital Imager) devices
- SEDECAL SM-40HF-B-D-CSedecal · Solid State X-Ray Imager (Flat Panel/Digital Imager)24 recalls1 report
- SEDECAL SM-40HF-B-D-VIRSedecal · Solid State X-Ray Imager (Flat Panel/Digital Imager)12 recalls1 report
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)7 recalls0 reports
- DigitalDiagnost C90 712034Philips Medical Systems DMC GmbH · Solid state x-ray imager (flat panel/digital imager)3 recalls90 reports
- DigitalDiagnost C90 712035Philips Medical Systems DMC GmbH · Solid state x-ray imager (flat panel/digital imager)4 recalls17 reports
- DigitalDiagnost 712031Philips Medical Systems DMC GmbH · Solid state x-ray imager (flat panel/digital imager)2 recalls65 reports
- NA GM85Samsung Electronics Co., Ltd. · Solid State X-Ray Imager (Flat Panel/Digital Imager)3 recalls4 reports
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)3 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.