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Terminated

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

FDA Recall Z-0827-2012 · Posted 2012-01-20

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2011-05-01
Date Terminated2014-01-24
Product Quantity3

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution - Including the states of Florida, Massachusetts and Wisconsin.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101666SYNGO. PLAZA VA20ASiemens AG Medical Solutions · 2010-08-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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