FDA recall Z-1691-2019

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

Reason for recall

Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2019-05-06

Report date

2019-06-05

Termination date

2020-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Danvers, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1691-2019