FDA-Device2013-08-07Class II

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

Siemens Medical Solutions USA, Inc
Hazard

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.

Sold states
US Distribution including the states of CA, IN, NJ and OK.
Affected count
4
Manufactured in
51 Valley Stream Pkwy, N/A, Malvern, PA, United States
Products
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1848-2013

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