Z-2404-2021Class II

Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee...

Name: Z-2404-2021 Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee...
Creator: Siemens Medical Solutions USA, Inc
Published: 2021-06-30
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2021-06-30 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q... on 2021-06-30. FDA classified it as Class II and gives the reason as "Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment". 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-2404-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-30
Posted: 2021-09-02
Terminated: 2023-02-10
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Angiography systems developed for single and biplane diagnostic imaging
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment
Root cause tag: software
FDA root cause: Software design
Action: Siemens Medical Solutions USA, Inc. issued a Customer Safety Advisory Notice to affected customers via AX045/21/S dated 6/30/21. Letter states reason for recall, health risk and action to take: If the BYPASS/ BYPASS FLUORO message does not disappear after approximately four minutes, an additional restart of the Artis system is necessary. Please follow the standard emergency procedures you have in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. Siemens will provide a software update for all affected systems via Update Instruction AX044/21/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. 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: 70 US (172 WW)
Distribution: US Nationwide distribution in the states of AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, ND, NE, NH, NJ, NV, NY, OH, PA, TN, TX, UT, VA, WA, WI.
Product codes and lots: Units with SW version VD12 Serial Numbers: 104005 104007 104012 104013 105500 105501 109645 110001 110005 110006 110007 110014 110016 110017 110018 110022 110023 110024 110025 110026 110027 110031 110032 110035 110036 110037 110039 110040 110041 110042 110043 110044 110046 110048 110051 111133 111500 111501 111502 111503 111504 111505 111506 111507 111508 111510 122001 122002 122005 122007 123501 123502 139012 150002 150003 150005 150009 150011 159010 159015 159021 159024 159025 159026 159028 159030 159032 159034 159037 159038

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2404-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2404-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-09-02

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)