Z-1533-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 29, 2017
- Initiation Date
- February 20, 2017
- Termination Date
- August 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 systems
Product Description
Syngo.plaza, Picture Archiving and Communications System (PACS) 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
Reason for Recall
Software updates
Distribution Pattern
Nationwide Distribution to MO,TX, FL, MA, WI, PA, IN, and CA
Code Information
Device Model Number: 10863171, 10863173 Serial Numbers: 100213 100484 100362 100457 100314 100300 100306 100307 100449 100450 100247 100221 100212