Z-0997-2013Class II

Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray...

Name: Z-0997-2013 Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray...
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-03-08
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-03-08 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system on 2013-03-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0997-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-08
Posted: 2013-03-26
Terminated: 2014-11-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
Product code: IZI System, X-Ray, Angiographic
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.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent a Customer Safety Advisory Notice on March 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the information on to all those who need to be aware of it and to instruct their personnel accordingly. Customers were asked to forward the safety information to other organizations that couald be affected by this action. For questions regarding this recall call 610-219-6300.
Quantity in commerce: 81
Distribution: Nationwide Distribution including AL, CA, CO, FL, IA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, ND, NJ, NY, OH, PA, SC, TX, UT, VA, WA, and WI and to Puerto Rico.
Product codes and lots: Model numbers 10094135, 10094137, 10094139, 10094141 and 10280959.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0997-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0997-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-26

Product code IZI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)