Recall Z-0997-2013— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0997-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-08

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2013-03-08, terminated 2014-11-06. It names 2 FDA 510(k) clearances: K090745, K073290. Product: Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system. Reason: The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap OGP (organ program) in the DSA overlay mode may lead to imprecise registration of the DSA mask image with the roadmap image displayed on the live monitor..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2013-03-08
Terminated: 2014-11-06
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K090745 — ARTIS ZEE / ZEEGOS WITH SW VC14Siemens Medical Solutions USA, Inc.·cleared 2009-06-18
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 Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system

Reason for recall

The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap OGP (organ program) in the DSA overlay mode may lead to imprecise registration of the DSA mask image with the roadmap image displayed on the live monitor.

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