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Terminated

Syngo Dynamics; Kinetdx Picture Archiving and Communications System

FDA Recall Z-1601-2016 · Posted 2016-05-04

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2016-04-14
Date Terminated2017-03-20
Product Quantity84 units

Reason for Recall

Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements.

Firm Action

Siemens mailed out a "Customer Advisory Notice" #SY009/16/P to customers informing them of the issue and what to do if it was to occur. Siemens informed customers that they are working on the "carry forward" feature enhancement and is planning to release a software update VA10B_HF06 and they should follow the instructions in the advisory notice until the update is performed.

Root Cause

Software design

Distribution Pattern

Nationwide: AZ, CA, IL, IN, MA, MD, MI, MN, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023772KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMAcuson Corp. · 2002-11-22

Official Source

View FDA Recall →

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

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