FDAMay 6, 2019device
Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital 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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.
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
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →