Z-0200-2022Class II

Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following...

Name: Z-0200-2022 Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following...
Creator: Siemens Medical Solutions USA, Inc
Published: 2021-09-24
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2021-09-24 / Open, Classified / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models... on 2021-09-24. FDA classified it as Class II and gives the reason as "Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0200-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-24
Posted: 2021-11-04
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application software models: Product/Model #: syngo X Workplace, 10281061 syngo X Workplace, 10281299 syngo X Workplace, 10502522 Syngo Application Software, 10848815
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Software error, the software can produce an incorrect interpretation of the table rotation if the table has been rotated by more than 4degrees in either direction. This can cause the 3D image reconstruction to be shown rotated by up to 5 degrees relative to the patient and to be used inappropriately by the system and result in incorrect treatment of the patient
Root cause tag: software
FDA root cause: Software design
Action: Siemens Healthineers issued Urgent Medical Device Correction Letter (AX059/21/S) dated 9/24/21. Letter states reason for recall, health risk and action to take: To avoid possible incorrect patient treatment, Siemens recommends a working position with 0 degree table rotation be used if intraoperative 3D images are required for subsequent steps (e.g., image superimposition, C-arm positioning, laser cross). If it should still be necessary to use a table rotation other than 0 degrees for intraoperative 3D images, please verify the C-arm position, needle position and image superimposition, by means of fluoroscopy. Siemens will provide a software update for all affected systems in which the system calculates table rotations and 3D reconstructions correctly. This corrective action will be distributed via Update Instruction AX058/21/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. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. 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: 43 US
Distribution: US Nationwide distribution.
Product codes and lots: Artis zeego systems with Artis patient table and AppSW VD20C/VD20N

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0200-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0200-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-10	2021-11-04

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)