FDA recall Z-1414-2023

NeuroLogica Corporation · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-03-08
Report date
2023-04-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Danvers, MA, United States

Primary source

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