Digital Diagnostic Mobile X-Ray System GM85
Brand(s)
Last updated
Summary
Product
Digital Diagnostic Mobile X-Ray System GM85
Issue
Medical devices - Performance
What to do
Customers to be contacted to arrange visit for inspection and repair.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Digital Diagnostic Mobile X-Ray System GM85 | S/N 5143M3UJ200001N | GM85 |
Issue
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Samsung Electronics Co., Ltd.
129, Samsung-Ro, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, South Korea, 16677
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78404
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