Z-1245-2022Class II

Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and...

Name: Z-1245-2022 Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and...
Creator: Siemens Medical Solutions USA, Inc
Published: 2022-04-11
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-04-11 / Open, Classified / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600 on 2022-04-11. FDA classified it as Class II and gives the reason as "if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1245-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-11
Posted: 2022-06-07
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
Root cause tag: design
FDA root cause: Device Design
Action: Siemens Medical Solutions USA, Inc. has initiated a Customer Safety Advisory Notice to all affected customers via AX027/21/S on 4/11/22. Siemens will conduct an inspection of the protective earth via Update Instruction AX026/21/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. Acknowledge Receipt of this Safety Advisory Notice 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: 51 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 04056869063317 Serial Number: 180062 180054 180019 180065 180056 180057 180041 180317 180034 180072 180060 180070 180048 180083 180315 180080 180301 180305 180067 180330 180040 180333 180029 180336 180316 180084 180334 180018 180046 180047 180335 180085 180035 180081 180331 180021 180321 180309 180323 180329 180043 180049 180077 180086 180053 180055 180015 180014 180066 180082 180037

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1245-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1245-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-07
Z-1246-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-07

Product code OWB

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)