Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report:12/4/2013
Class lI:
PRODUCT
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified fluoroscopic x-ray system
Recall Number Z-0140-2014
REASON
A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed images that are not of diagnostic quality.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 9/3/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
59
DISTRIBUTION
Nationwide and Canada
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