Device 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.
Z-2719-2015
Product summary
- Event
- Event 71978
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37
- Official record key
device-enforcement:Z-2719-2015
Official wording
Reason: Potential issue leading to data loss and patient data mix-up
Code information: Model Number of device 10592457 with serial numbers: Serial 100544 100499 100600 100571 100263 200308 200309 200310 200311 200312 200313 200314 200315 200316 200317 200318 200319 200320 200321 200322 200323 200324 100146 200277 100177 100138 100174 100491 100492 100596 100198 100181 200251 200252 100301 100302 100539
Distribution pattern: US Nationwide Distribution - in the states of CA, OR, FL, MO, NY, WA, MD, MA, NY, WI, KS, MN and PA.
Derived failure modes
-
Unknown
Potential issue leading to data loss and patient data mix-up