FDAClass IIAugust 7, 2013

Siemens Luminos dRF Fluoroscopic X-Ray system recall: Software Issue

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

Why was Siemens Luminos dRF Fluoroscopic X-Ray system 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model number 10094200, serial numbers 4024, 4077, 4043 and 4051

Product
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
4
Distribution
US Distribution including the states of CA, IN, NJ and OK.
Recall date
August 7, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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