PlainRecalls
FDA Devices Moderate Class II Terminated

Artis zee multi, Model Number 10094139

Reported: July 31, 2019 Initiated: June 12, 2019 #Z-2030-2019

Product Description

Artis zee multi, Model Number 10094139

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.

Details

Units Affected
89
Distribution
US Nationwide Distribution
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Artis zee multi, Model Number 10094139. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 89.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 31, 2019. Severity: Moderate. Recall number: Z-2030-2019.