Z-0524-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2018
- Initiation Date
- August 23, 2017
- Termination Date
- October 1, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 76
Product Description
Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 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.
Reason for Recall
When a prior study is being replaced in the workflow step, in certain scenarios (based on the Display Protocol configuration) the prior study will only be replaced in the active Workflow Step and not show in all other workflow steps. The other workflow steps will continue to show the initially loaded study.
Distribution Pattern
US Nationwide Distribution
Code Information
Model Number - 10863171, 10863172, 10863173