Company:Siemens Medical Solutions USA, Inc
Date of Enforcement Report 2/1/12
Class ll:
PRODUCT
Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457. Recall # Z-0827-2012
REASON
The firm has become aware of the potential for an unintended merge of multiple patients when using syngo.plaza version VA20 with Server Farm setup integrated to a RIS. Sporadically it can happen that certain Patient IDs in the database are deleted and sent to NULL. This can cause incorrect merging with patients that already had a NULL Patient ID.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter in May 2011.
Manufacturer: Siemens AG, Medical Solutions, Business Unit XP, Erlangen, Germany. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3
DISTRIBUTION
Nationwide
