Z-0297-2022Class II

Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging...

Name: Z-0297-2022 Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging...
Creator: Siemens Medical Solutions USA, Inc
Published: 2021-10-20
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2021-10-20 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137 on 2021-10-20. FDA classified it as Class II and gives the reason as "If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure". 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-0297-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-20
Posted: 2021-11-24
Terminated: 2024-06-18
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
Root cause tag: software
FDA root cause: Software design
Action: Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice dated 10/202/1 to customers via AX070/21/S, Siemens will update the system software via Update Instruction AX069/21/S. Letter states reason for recall, health risk and action to take: To avoid the problem, it is recommended to position the SID first and then release x-ray. Siemens will correct the software error (software VD12) via Update Instruction AX069/21/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. We do not consider it necessary to re-examine any patients in relation to the issues described above. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein
Quantity in commerce: 8 units
Distribution: US Nationwide Distribution
Product codes and lots: Serial Numbers: Serial 150002 150017 125700 150005 150023 150009 150015 150003 Expanded Recall 11/15/21: 147120 147119 150011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0297-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0296-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0297-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0298-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0299-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0300-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0301-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0302-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0303-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0304-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-24
Z-0305-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-24

Product code OWB

K181407Class IIArtis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. / cleared 2018-08-15

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)