Z-0481-2016Class II

Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray...

Name: Z-0481-2016 Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray...
Creator: Siemens Medical Solutions USA, Inc
Published: 2015-10-30
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2015-10-30 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures on 2015-10-30. FDA classified it as Class II and gives the reason as "Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the field and only...". 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-0481-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-30
Posted: 2015-12-24
Terminated: 2017-03-28
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Due to improper soldering in a limited number of large display bypass module components of a specific production lot, a loss of video signal could potentially occur. This has not been observed in the field and only sporadic cases have been observed in factory screening.
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an Important Customer Safety Notice dated October 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The issue will be remedied with a hardware update AX025/15/S. The affected bypass module hardware will be exchanged with unaffected production lots to eliminate the problem. For further questions call: (610) 219-6300.
Quantity in commerce: 17
Distribution: US Distribution to the states of : IL, WI, MA, FL, AL, TN, ND, OH, TX, CA, NJ and MI.
Product codes and lots: Model numbers 10094135, 10094137, 10094141, 10848280, 10848281, 10848282, 10848355. Serial Numbers 123026, 147909, 123031, 103030, 147912, 147910, 147921, 147919, 131005, 121096, 125004, 137551, 121088, 109104, 109105, 109107, and 121085.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0481-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0481-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-24

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)