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Digital diagnostic mobile x-ray system gm85

Official notice

28 Oct 2025

Last checked

28 Oct 2025

High riskHealth Canada

An official Health Canada notice concerns Digital diagnostic mobile x-ray system gm85. 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. Published 2025-10-28.

What to do now

Customers to be contacted to arrange visit for inspection and repair.

Recall number

78404

Official notice

2025-10-28

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

78404

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Affected products

Product 1

Affected products - Digital Diagnostic Mobile X-Ray System GM85, Lot or serial number - S/N 5143M3UJ200001N, Model or catalogue number - GM85

Risk / 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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Samsung, Digital Diagnostic Mobile X-ray System Gm85.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

high

Recall details

Recall number

78404

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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