CanadaThe Digital Diagnostic Mobile X‑Ray System GM85 (model GM85, serial number S/N 5143M3UJ200001N) is affected. It was recalled because bolts connecting the tube head unit (THU) to the arm may loosen or break from metal fatigue, which could allow the THU to detach and pose a risk of serious injury; customers will be contacted to arrange an inspection and repair.
What's being recalled
Companies: Samsung Electronics Co., Ltd., 129, Samsung-Ro, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, South Korea, 16677.
How to identify it
Affected products: Digital Diagnostic Mobile X-Ray System GM85; Lot or serial number: S/N 5143M3UJ200001N; Model or catalogue number: GM85
The hazard
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
Customers to be contacted to arrange visit for inspection and repair.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)