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Terminated

Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA Recall Z-1705-2015 · Posted 2015-06-03

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2015-05-15
Date Terminated2017-03-24
Product Quantity167

Reason for Recall

measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print.

Firm Action

Siemens sent a Customer Advisory Notice, dated May 15, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to check the software version of their syngo.via system and consider whether the issue described in the advisory notice impact their clincal coutine and whether to arrange the installation of SY027/15/P (VA30A_HF07). Customers were advised to include the advisory notice in their operator's manual. Customers were also advised to notify anyone at their organization who should be aware of this information. For questions regarding this recall call 610-219-6300.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123375SYNGO.VIASiemens AG · 2012-11-20K092519SYNGO.XSiemens AG Medical Solutions · 2009-08-27

Official Source

View FDA Recall →

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

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