Siemens Medical Solutions USA, Inc recalls Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, ma

Recalled September 28, 2016 · FDA recall Z-2852-2016 · Siemens Medical Solutions USA

Hazard

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. · FDA Class II

Units

338 systems

Sold at

Distributed Nationwide

Description

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.

Product

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.

Manufacturer(s)

Siemens Medical Solutions USA, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →