PlainRecalls
FDA Devices Moderate Class II Terminated

Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.

Reported: September 21, 2016 Initiated: August 2, 2016 #Z-2794-2016

Product Description

Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.

Reason for Recall

Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.

Details

Units Affected
101 Systems
Distribution
Nationwide Distribution
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 101 Systems.
Why was this product recalled?
Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value may be different from the real value.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 21, 2016. Severity: Moderate. Recall number: Z-2794-2016.