Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report 2/1/12
Class ll:
PRODUCT
Syngo Imaging XS, all versions Radiological image processing system. Model number 10496279. Recall # Z-0514-2012
REASON
The “Rename” functionality can cause an unintended patient merge if the renamed patient is sent to another system.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated August 3, 2011.
Manufacturer: Siemens AG, Medical Solutions, Business Unit XP, Erlangen, Germany. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
38
DISTRIBUTION
Nationwide
