FDASeptember 14, 2015device
Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. The system can be stopped by releasing the drive handle or by pressing the emergency switch. Proper behavior is re-enabled when the system is rebooted.
What to do
FDA enforcement status: Terminated
Brands named
neurologica
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAGM85 Digital Mobile X-ray imaging System; Model Number: GM85;2025-10-07
- FDAGM60A. Digital Diagnostic Mobile X-Ray System.2024-07-08
- FDASamsung Digital Diagnostic Mobile X-ray System, Model GM85.2023-12-28
- FDAOmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL50002023-06-06
- FDASamsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System2023-03-08
- FDAOmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.2020-07-15
- FDAWS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01.06, 3.01.07, 3.01.08, 3.01.09, 4.00.08, 4.00.09, 4.00.10, 4.00.11, 4.01.00, 4.01.01, 4.01.02, 4.01.03, 4.01.04, 4.01.05, 4.01.06, 4.01.07, 4.01.08, 4.01.09.2019-07-25
- FDAHS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.122019-07-25
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