Kinetdx Picture Archiving and Communications System

• • Terminated Z-1601-2016 FDA Class II ·initiated 14 Apr 2016

  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.

• • Terminated Z-0826-2016 FDA Class II ·initiated 29 Jan 2016

  Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.

• • Terminated Z-1183-2016 FDA Class II ·initiated 25 Jan 2016

  Siemens' conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics.

• • Terminated Z-1613-2014 FDA Class II ·initiated 3 Apr 2014

  Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display.

• • Terminated Z-1216-2014 FDA Class II ·initiated 27 Jan 2014

  Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis.

510(k) Number

K023772 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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