Public recall detail

Digital Diagnostic Mobile X-Ray System GM85

2025-10-28

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Recall Safety notice
Quick summary

Quick summary: Digital Diagnostic Mobile X-Ray System GM85. Date: 2025-10-28.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Digital Diagnostic Mobile X-Ray System GM85. Date: 2025-10-28.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandSamsung Electronics Co., Ltd.
ProductDigital Diagnostic Mobile X-Ray System GM85
IssueMedical devices - Performance
Recall classType II
IdentificationRA-78404

Affected products

ProductDigital Diagnostic Mobile X-Ray System GM85
LotS/N 5143M3UJ200001N
ModelGM85
Serial numberS/N 5143M3UJ200001N
DescriptionDigital Diagnostic Mobile X-Ray System 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.

What you should do

  • Customers to be contacted to arrange visit for inspection and repair.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesSamsung Electronics Co., Ltd. 129, Samsung-Ro, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, South Korea, 16677
Recall date2025-09-30
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-78404
Background{}
CompaniesSamsung Electronics Co., Ltd. 129, Samsung-Ro, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, South Korea, 16677
AudiencesHealthcare
Source updated2025-10-28

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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