Z-1288-2021Class II

Interventional Fluoroscopic X-Ray System -

Name: Z-1288-2021 Interventional Fluoroscopic X-Ray System -
Creator: Siemens Medical Solutions USA, Inc
Published: 2021-02-26
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2021-02-26 / Terminated / root cause: design

FDA source

Siemens Medical Solutions USA, Inc began a recall of Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not... on 2021-02-26. FDA classified it as Class II and gives the reason as "Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1288-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-26
Posted: 2021-03-22
Terminated: 2021-08-11
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 2/26/2021, Siemens issued an Urgent Medical Device Correction notice to in inform customers of a possible hazard to patients, operators, or other persons and equipment due to a hardware error which affects ARTIS icono /pheno systems in combination with imaging system UPS (Uninterrupted Power Supply) option. This potential hardware issue has no influence on the previous treatment/diagnosis of patients. However, in case of error, planned procedures may have to be terminated and performed on an alternative x-ray system. Based on our investigation, you can continue to safely use your system.
Quantity in commerce: 29 systems
Distribution: US Nationwide distribution in the states of MI, KY, TX.
Product codes and lots: ARTIS Icono biplane- 11327600 ARTIS Icono floor- 11327700

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1288-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1288-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-22

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)