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Terminated

syngo Imaging Version V31 Picture Archiving and Communication System, model number 10014063.

FDA Recall Z-1650-2009 · Posted 2009-07-07

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2009-06-01
Date Terminated2013-03-19
Product Quantity16 units

Reason for Recall

Risk of misinterpretation of patient response to treatment: Date displayed may be incorrect. Filtering based on examination date may lead to an incorrect list of examinations.

Firm Action

syngo Imaging has issued a Customer Safety Advisory Notice, dated May 28, 2009, to affected customers via Update Instruction IM019/09/S. The notice informs the customers of the potential issue and provides instructions to avoid its occurrence. A software update to correct this issue is currently being developed and will be installed on affected systems by sygo's service representatives when it becomes available.

Root Cause

Software design

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081734SYNGO IMAGING (VERSION V31)Siemens AG Medical Solutions · 2008-07-03

Official Source

View FDA Recall →

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

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