PlainRecalls
FDA Devices Moderate Class II Terminated

AXIOM Artis TA, Model Number 7007755

Reported: July 31, 2019 Initiated: June 12, 2019 #Z-2018-2019

Product Description

AXIOM Artis TA, Model Number 7007755

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
5
Distribution
US Nationwide Distribution
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
AXIOM Artis TA, Model Number 7007755. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 5.
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-2018-2019.