FDA recall Z-1288-2021

Siemens Medical Solutions USA, Inc · Class II · device

Product

Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Reason for recall

Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.

Distribution

US Nationwide distribution in the states of MI, KY, TX.

Key facts

Status
Terminated
Initiation date
2021-02-26
Report date
2021-03-31
Termination date
2021-08-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1288-2021