PlainRecalls
FDA Devices Moderate Class II Terminated

Siemens syngo.plaza. Radiological image processing system

Reported: August 1, 2012 Initiated: February 24, 2012 #Z-2078-2012

Product Description

Siemens syngo.plaza. Radiological image processing system

Reason for Recall

Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.

Details

Units Affected
2
Distribution
(USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Siemens syngo.plaza. Radiological image processing system. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 2.
Why was this product recalled?
Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 1, 2012. Severity: Moderate. Recall number: Z-2078-2012.