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Terminated

Siemens syngo.plaza. Radiological image processing system

FDA Recall Z-2078-2012 · Posted 2012-07-26

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2012-02-24
Date Terminated2014-01-14
Product Quantity2

Reason for Recall

Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.

Firm Action

Siemens sent a Customer Safety Advisory Notice letter dated February 24, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to ensure that the prefix defined in the viewer settings for "Content Creator's Initials" is not empty. Then all images will be display correctly. This has to be checked for every user. Further questions please call 610-219-6300.

Root Cause

Software design

Distribution Pattern

(USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.

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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