Recall Z-1699-2018— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2018-02-20, terminated 2019-07-16. It names one FDA 510(k) clearance: K132532. Product: Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 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: Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-20
- Terminated
- 2019-07-16
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173 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 upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.
Data sourced from openFDA. This site is unofficial and independent of the FDA.