| 2025-10-07 |
Class II
|
Ongoing |
Z-0480-2026 |
GM85 Digital Mobile X-ray imaging System; Model Number: GM85; |
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The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue. |
| 2024-07-08 |
Class II
|
Ongoing |
Z-2715-2024 |
GM60A. Digital Diagnostic Mobile X-Ray System. |
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Potential for the anti-fall system of the device arm to fail. |
| 2023-12-28 |
Class II
|
Ongoing |
Z-1056-2024 |
Samsung Digital Diagnostic Mobile X-ray System, Model GM85. |
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Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm. |
| 2023-06-06 |
Class II
|
Ongoing |
Z-2068-2023 |
OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, prim… |
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1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. … |
| 2023-03-08 |
Class II
|
Ongoing |
Z-1414-2023 |
Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System |
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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 |
| 2020-07-15 |
Class II
|
Terminated |
Z-2772-2020 |
OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Produ… |
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There are potential issues related to the operational state of the scanner, specifically for transport and inadvertent system shutdowns. There could be a possib… |