Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 3/14/12
Class ll:
PRODUCT
Siemens syngo Imaging XS. Radiological image processing system. Model number 10496279. Recall # Z-1064-2012
REASON
Firm became aware of an unintended behavior when using syngo Imaging XS, version VA70A and VA70B with Client/Server Installations. Loading additional images/series from the Patient Browser using the thumbnails may cause unintended deletion of images/series. In response, firm issued a Customer Safety Advisory Notice to affected customers via Update Instructions SY047/11/S. Additionally; firm became aware of an unintended behavior when using syngo Imaging XS, all versions. The “Rename” function may cause an unintended patient merge if the renamed patient is sent to another system. In response to this issue, firm distributed a Customer Safety Advisory Notice to affected customers via Update Instructions SY038/11/S. Both letters informed customers of the potential issues and provided additional information on the implemented resolution. The current Update Instruction SY055/11/S is the subsequent measure announced in the customer safety advisory notices UI SY047/11/S and UI SY038/11/S. To remedy the issues described in customer safety advisory notices, a software update package VA70B_0211 is being released.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on January 26, 2011.
Manufacturer: Siemens AG, Medical Solutions, Business Unit XP, Erlangen, Germany. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
128 units
DISTRIBUTION
Nationwide