FDA recall Z-2016-2019

Siemens Medical Solutions USA, Inc · Class II · device

Product

AXIOM Artis BA, Model Number 5904656

Reason for recall

A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

Distribution

US Nationwide Distribution

Key facts

Status: Terminated
Initiation date: 2019-06-12
Report date: 2019-07-31
Termination date: 2020-09-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2016-2019