PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: March 31, 2021 Initiated: February 26, 2021 #Z-1288-2021

Product Description

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.

Details

Units Affected
29 systems
Distribution
US Nationwide distribution in the states of MI, KY, TX.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 29 systems.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 31, 2021. Severity: Moderate. Recall number: Z-1288-2021.