FDA recall Z-3036-2017

Product

Samsung GU60A system- Digital X-ray Imaging Systems are 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

When performing the Stitching function on GU60A system, unintended area is exposed to radiation

Distribution

Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2017-05-24

Report date

2017-09-06

Termination date

2018-07-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Danvers, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3036-2017