FDAMarch 8, 2023device
Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm
What to do
FDA enforcement status: Ongoing
Brands named
neurologica
UPCs
08806088582412
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
- 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
- FDASamsung 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 applications2019-05-06
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