Z-0016-2014Class II

Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F...

Name: Z-0016-2014 Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F...
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-05-06
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-05-06 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems on 2013-05-06. FDA classified it as Class II and gives the reason as "Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exists that radiation...". 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-0016-2014
Classification: Class II
Status: Terminated
Initiated: 2013-05-06
Posted: 2013-11-01
Terminated: 2014-11-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exists that radiation may continue longer than expected and may result in unnecessary dose applied during an acquisition. Additionally, it is not possible for the user to stop the radiation manually; ho
Root cause tag: software
FDA root cause: Software design
Action: Siemens initiated this correction on May 6, 2013 by sending Update InstructionXP005/13/S. Firm subsequently issued a letter on June 3, 2013 to all accounts. 1. Siemens Field Modification of the Luminos dRF, Ysio & Uroskop Omina running software versions VB10D, VB10F, VB10C and VB10E, which improves the signal transmission for the automatic exposure control, is available as of May 2013, and systems will be updated within one year. 2. The revised software fix for models Luminos dRF, Ysio & Uroskop Omina running software versions VB10D, VB10F, VB10C and VB10E, will be provided to all identified customers at no charge. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Siemens Medical Solutions USA, Inc., will notify the FDA district office in Philadelphia, Pennsylvania, with reports of progress regarding this field correction.
Quantity in commerce: 23
Distribution: Nationwide Distribution
Product codes and lots: Material 10094910, with serial numbers 1036, 1045, 1025, 1040, 1041, 1032, 1047 and 1035; Material 10281013, with serial numbers 21221, 21223, 21213, 21089, 21098, 21163, 21171, 21194, 21212, 21186, 21188, 21167, 21187 and 21189; Material 10281163, with serial number 31114.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0016-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0016-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-01

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)