Recall Z-2018-2019— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2018-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-12

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2019-06-12, terminated 2020-09-18. It names one FDA 510(k) clearance: K052202. Product: AXIOM Artis TA, Model Number 7007755. Reason: 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2019-06-12
Terminated: 2020-09-18
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K052202 — AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEMSiemens Medical Solutions USA, Inc.·cleared 2006-03-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.