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.
FDA Recall Z-1354-2015 · Posted 2015-03-30
Advertisement
Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeLLZ
Date Initiated2015-02-18
Date Terminated2016-08-17
Product Quantity4
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farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived.
Firm Action
Safety Advisory Notice, dated February 18, 2015, was sent to end users that identified the product, problem, and action to be taken. Users were advised not to manually remove the delete protection in the STS.
Root Cause
Software design
Distribution Pattern
US Distribution: MA, WI, FL
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement