Official recall record
Digital Diagnostic Mobile X-Ray System GM85
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-10-28
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
We have received a report regarding the loosening or breakage of bolts that connect the tube head unit (THU) to the arm. An investigation determined that this may be caused by metal fatigue resulting from accumulated stress over a long period of use. If all connecting bolts were to fail, it could potentially cause the THU to detach from the arm, posing a risk of serious injury to a patient or user.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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