Z-1782-2013Class II

ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and...

Name: Z-1782-2013 ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and...
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-06-26
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-06-26 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system on 2013-06-26. FDA classified it as Class II and gives the reason as "Siemens issued a customer safety advisory notice and field safety corrective action for a potential issue on Artis systems with Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. The issue...". 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-1782-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-26
Posted: 2013-07-22
Terminated: 2015-02-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Siemens issued a customer safety advisory notice and field safety corrective action for a potential issue on Artis systems with Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. The issue affects-DSA rotational acquisition. The restriction is related to any rotational 3D-acquisition program with real-time subtraction (e.g. 3D DSA). During the fill phase of the rotational aqui
Root cause tag: software
FDA root cause: Software Design Change
Action: Siemens sent a Customer Safety Advisory Notice dated June 26, 2013, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers were strongly recommend to carefully evaluate one of the following options before running 3D rotational acquisition programs that include real-time subtraction until a patch is installed on their system: 1) position the monitor in a way such that contrast advancement can be monitored during the fill phase on the live monitor in the control room. 2) For applications not requiring actions based on the contrast flow during the fill phase, the contrast may not need to be monitored during the fill phase. Although the monitor is not showing the expected subtraction, the acquisition is working correctly. There is no need to interrupt, but continue and finish the workflow. 3) Perform 3D rotational programs that include real time subtraction from the exam room. The display on the live monitor in the exam room is not affected by this problem. To resolve the issue, the update AX028/13/P (VC20x/VC21B), will be made available around July 2013, and scheduling an appointment for implementation of the update with Siemens Customer Service organization was recommended. If this device/equipment is no longer in theirr possession, customers were asked to forward this safety notice to the new owner and inform Siemens of the new user's identity.
Quantity in commerce: 29
Distribution: Nationwide Distribution and Puerto Rico
Product codes and lots: Model numbers: 10094137, 10094139, 10094141, 10280959

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1782-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1782-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)