Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0827-2012

Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457

Siemens Medical Solutions USA, Inc. / initiated 2011-05-01 / Terminated / root cause: software

Siemens Medical Solutions USA, Inc began a recall of Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457 on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0827-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457.
Product code
LLZ System, Image Processing, Radiological
Reason for recall
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.
Root cause tag
software
FDA root cause
Software design
Action
The firm initiated their product recall in May 2011 by issuing a "Customer Safety Advisory Notice" informing all customers of the malfunction and providing instructions on how to avoid the error. The issue will be solved with the next version release, planned for June 2011.
Quantity in commerce
3
Distribution
Nationwide Distribution - Including the states of Florida, Massachusetts and Wisconsin.
Product codes and lots
Model number 10592457, serial numbers 100174, 100177, and 100181.