—#119218

Product

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

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K062623
Affected lot / code info: Model number 10094200, serial numbers 4024, 4077, 4043 and 4051

Why it was 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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: US Distribution including the states of CA, IN, NJ and OK.

Timeline

Recall initiated: 2013-05-07
Posted by FDA: 2013-08-01
Terminated: 2013-12-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119218. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.