PlainRecalls
FDA Devices Moderate Class II Terminated

Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system

Reported: August 21, 2013 Initiated: March 4, 2013 #Z-1975-2013

Product Description

Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system

Reason for Recall

Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.

Details

Units Affected
6
Distribution
Nationwide distribution: FL, MA, KS, NY, OH, PA, TX and WI.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 6.
Why was this product recalled?
Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 21, 2013. Severity: Moderate. Recall number: Z-1975-2013.