Recall Z-0481-2016— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0481-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-30

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2015-10-30, terminated 2017-03-28. It names 2 FDA 510(k) clearances: K123529, K073290. Product: Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.. Reason: Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the field and only sporadic cases have been observed in factory screening..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2015-10-30
Terminated: 2017-03-28
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K123529 — ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEMSiemens Medical Solutions USA, Inc.·cleared 2013-02-26
K073290 — ARTIS ZEE AND ZEEGOSiemens Medical Solutions USA, Inc.·cleared 2008-02-11

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

Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.

Reason for recall

Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the field and only sporadic cases have been observed in factory screening.

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