The Recall Desk
HighFDA (Devices)·Z-1691-2019·Announced 2019-06-05

NeuroLogica Recalls Samsung GM85 Mobile Digital X-ray Imaging Systems

NeuroLogica is recalling 288 Samsung GM85 Mobile Digital X-ray Imaging Systems due to a potential safety latch issue that could cause the arm to fall.

What this means for you

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: The recall involves a risk-of-harm product (potential bodily injury from a falling arm) where no injuries have been reported yet, fitting the 'High' severity criteria for theoretical hazards.

Plain-English summary

NeuroLogica Corporation is recalling 288 units of the Samsung GM85 Mobile Digital X-ray Imaging System. The recall is due to a potential issue with the operation of the safety latch within the column that supports the arm. This defect could result in the arm falling in the unlikely event that the column wire breaks, posing a risk of bodily harm.

The affected systems were distributed nationwide in the United States. The device is intended for use by qualified doctors or technicians to generate radiographic images of human anatomy and is not intended for mammographic applications.

Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. If a unit is affected, it should be removed from service and the recalling firm contacted for further instructions.

The recalled product

Product
Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
Affected units
288

Distribution

Distributed nationwide across the United States.