FDA recall Z-2402-2019

Siemens Medical Solutions USA, Inc · Class II · device

Product

SOMATOM go.All; Models #11061630 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data

Reason for recall

The injector holder could potentially fall off together with the injector and the storage box.

Distribution

US Nationwide Distribution in the states FL KS WI NE MS OH TX NY LA IN IL OK MI GA NJ AK CT AL MD

Key facts

Status: Terminated
Initiation date: 2019-07-31
Report date: 2019-09-04
Termination date: 2020-12-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2402-2019