FDA recall Z-2449-2019

Product

Proteus XR/a (SlOK : K993090)

Reason for recall

Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.

Distribution

Worldwide - US Nationwide

Key facts

Status

Ongoing

Initiation date

2019-08-09

Report date

2019-10-02

Voluntary/Mandated

FDA Mandated

Location

Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2449-2019