Z-1848-2013Class II

Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system

Name: Z-1848-2013 Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2013-05-07
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2013-05-07 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system on 2013-05-07. FDA classified it as Class II and gives the reason as "Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into an upright position and may...". 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-1848-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-07
Posted: 2013-08-01
Terminated: 2013-12-24
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into an upright position and may collide with the floor. Four consignees were notified of this recall by Update Instruction XP067/12/S -- all four units have been corrected.
Root cause tag: software
FDA root cause: Software design
Action: Siemens initiated their correction of this product in May, 2013 by sending an Safety Update Instruction XP067/12S to resolve the software error to all affected customers. All units have been corrected. Further questions please call (610)-219-6300.
Quantity in commerce: 4
Distribution: US Distribution including the states of CA, IN, NJ and OK.
Product codes and lots: Model number 10094200, serial numbers 4024, 4077, 4043 and 4051

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1848-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1848-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-08-01

Product code OWB

K062623Class IIAxiom Luminos DrfSiemens Medical Solutions USA, Inc. / cleared 2007-08-22

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)