Cl II Siemens syngo.plaza

Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 11/20/2013
Class lI:

PRODUCT

Siemens syngo.plaza image processing system image processing radiological system
Recall Number Z-0271-2014

REASON
The firm became aware of an unintended behavior when using the syngo.plaza. The “Rename” functionality can cause an unintended patient merge if the patient is sent to another system. This issue affects customers who transfer patient data between two or more syngo.plaza or syngo Imaging XS systems.

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Malvern, PA on 8/8/2011. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
19

DISTRIBUTION
Nationwide

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