FDA-Device2023-04-26Class II

Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System

NeuroLogica Corporation
Hazard

Issue related to the operation of the arm latch within the column that supports the arm, potential bodily harm due to a fall of the arm

Sold states
US Nationwide distribution.
Affected count
935 units
Manufactured in
14 Electronics Ave, N/A, Danvers, MA, United States
Products
Samsung GM85 Digital X-ray Imaging System-A Digital Diagnostic Mobile X-ray System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1414-2023

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief