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Terminated

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

FDA Recall Z-1848-2013 · Posted 2013-08-01

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2013-05-07
Date Terminated2013-12-24
Product Quantity4

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062623AXIOM LUMINOS DRFSiemens Medical Solutions USA, Inc. · 2007-08-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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