PlainRecalls
FDA Devices Moderate Class II Terminated

Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.

Reported: April 8, 2015 Initiated: February 18, 2015 #Z-1354-2015

Product Description

Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.

Reason for Recall

Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived.

Details

Units Affected
4
Distribution
US Distribution: MA, WI, FL
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 4.
Why was this product recalled?
Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 8, 2015. Severity: Moderate. Recall number: Z-1354-2015.