Z-0695-2020Class II

Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C

Name: Z-0695-2020 Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-11-14
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-11-14 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C on 2019-11-14. FDA classified it as Class II and gives the reason as "In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating tabletop and could result in a delay or interruption of a...". 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-0695-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-14
Posted: 2019-12-17
Terminated: 2020-05-12
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating tabletop and could result in a delay or interruption of a procedure.
Root cause tag: software
FDA root cause: Software design
Action: On November 14, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: URGENT: MEDICAL DEVICE CORRECTION Dear Customer, This letter is to inform you of a corrective action that will be performed to prevent a possible hazard to patients, operators, or other persons and equipment due to a potential software error in software version VC21C and serial numbers 140422, 140423 or 140430. Artis zee systems with software version VC21C and serial # 140422, 140423 or 140430 This potential software issue has no influence on the previous treatment/diagnosis of patients. However, in case of software failure, planned procedures may have to be terminated and perfomed on an alternative x-ray system. What is the underlying issue requiring corrective action and when does the issue occur? In affected Artis systems, the movement of the floating tabletop may become blocked after a collision sensor has been activated during system movements. The collision supervision will display a user message on the monitor. What is the impact on system operation and what are the potential risks? During normal operation, activation of a collision sensor will cause a block of any system movements but moving the floating tabletop is still possible. In affected Artis systems, the movement of the floating tabletop is blocked and could result in a delay or interruption of a procedure. We do not consider it necessary to re-examine any patients in this case as this possible software error had no influence on treatment of patients. How was the issue detected, what is the cause, and what action will be taken? The issue was detected during regular field monitoring. The root cause for the blocked tabletop movement (horizontally and vertically) is a software error of the stand control unit. By using the safety override function and moving out of the collision zone, the system movement can be resumed. In safety override mode you may try to resolve a coll
Quantity in commerce: 3
Distribution: US: WA and TX International: Denmark
Product codes and lots: Model Number: 10094142 Serial Number: 140422, 140423, 140430 Software Version: VC21C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0695-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0695-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-17

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)