PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: August 7, 2013 Initiated: May 7, 2013 #Z-1848-2013

Product Description

Siemens Luminos dRF Fluoroscopic X-Ray system 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.

Details

Units Affected
4
Distribution
US Distribution including the states of CA, IN, NJ and OK.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 4.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 7, 2013. Severity: Moderate. Recall number: Z-1848-2013.