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Siemens Medical Solutions USA, Inc recalls Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Commu
Recalled September 9, 2015 · FDA recall Z-2719-2015 · Siemens Medical Solutions USA
Hazard
Potential issue leading to data loss and patient data mix-up · FDA Class II
Units
37
Sold at
US Nationwide Distribution - in the states of CA, OR, FL, MO, NY, WA, MD, MA, NY, WI, KS, MN and PA.
Description
Potential issue leading to data loss and patient data mix-up
Product
Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is 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. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →