Z-1144-2021Class II

ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B -

Name: Z-1144-2021 ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B -
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-12-18
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-12-18 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane... on 2020-12-18. FDA classified it as Class II and gives the reason as "Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error management, Erroneous error...". 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-1144-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-18
Posted: 2021-02-23
Terminated: 2021-11-17
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error management, Erroneous error messages, Zoom/Pan Function, Grid Indication, and Coolant Level. May cause procedures to be terminated and performed on an alternative x-ray system
Root cause tag: software
FDA root cause: Software design
Action: Siemens Medical Solutions USA, Inc. issued a Customer Safety Advisory Notice to all affected customers via AX080/20/S. on 12/28/20. Letter states reason for recall, health risk and action to take: Siemens will provide a software update to all affected customers which will correct the issue via Update Instruction AX070/20/S. The Operator Manual addendum to the Instruction for Use for VE20 has been updated and includes the missing information about the grid indication Our service organization will contact you to arrange a date to perform this corrective action. Please feel free to contact our service organization at 1-800-888-7436.
Quantity in commerce: 41 U.S
Distribution: US Nationwide distribution.
Product codes and lots: Software version VE20B. Serial Numbers: Serial 180054 180062 180019 180065 180056 180057 180041 180084 180034 180072 180060 170026 180070 180048 180083 180080 180067 180040 180029 170023 180068 170025 180018 180047 180046 180085 180035 180081 170051 170027 180043 170053 180049 180077 180053 180055 180015 180014 180066 180082 180037

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1144-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1144-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-23

Product code OWB

K193326Class IIARTIS IconoSiemens Medical Solutions USA, Inc. / cleared 2020-04-16

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)