Samsung GM85 Digital X-ray Imaging System Arm Latch Failure
NeuroLogica Corporation recalls 935 Samsung GM85 digital X-ray systems due to a faulty arm latch in the column support that could allow the arm to fall, creating a risk of bodily injury.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with a structural defect in a mechanical component that poses a risk of bodily injury. No hospitalizations or injuries have been reported, placing this at the High severity level per the rubric for risk-of-harm products without reported illness.
Plain-English summary
NeuroLogica Corporation is recalling 935 Samsung GM85 Digital X-ray Imaging Systems distributed nationwide in the United States. The recall addresses a defect in the arm latch mechanism within the column that supports the imaging arm.
The arm latch may fail to remain securely latched, which could result in the arm falling unexpectedly. This creates a potential risk of bodily harm to operators and patients in the vicinity of the equipment during operation or when the arm is being repositioned.
No injuries or illnesses have been reported in connection with this defect. Facilities using the affected Samsung GM85 systems should stop using the equipment and contact NeuroLogica Corporation or an authorized service representative for inspection and repair instructions. A complete list of affected serial numbers is available through the FDA and the manufacturer.
The recalled product
- Product
- Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System
- Manufacturer
- NeuroLogica Corporation
- Affected units
- 935
Distribution
Distributed nationwide across the United States.
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