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Terminated

Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA Recall Z-2852-2016 · Posted 2016-09-21

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-08-05
Date Terminated2017-08-22
Product Quantity338 systems

Reason for Recall

Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high.

Firm Action

Siemens sent an Customer Letter dated August 5, 2016, to all affected customers. The letter identified the product the problem and the action need to be taken by the customer. The letter informed customers of a software change VB10B_HF02 that they have implemented to address several issues. If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. For further questions please call (610) 219-4834.

Root Cause

Software design

Distribution Pattern

Distributed Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092519SYNGO.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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