Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Recall Z-2853-2016 · Posted 2016-09-21
Advertisement
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement