FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Syngo.plaza software 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.
- Recall number
- Z-1700-2018
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Syngo.plaza software 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.
- Status
- Terminated
- Initiated
- 2018-02-20
- Posted
- not on file
- Terminated
- 2019-07-16
- Reason
- Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis.
- Root cause
- Software design
- Action
- On February 25, 2018 a Customer Information Letter was mailed to customers. This notification informed customers of the software changes related to All Sygno.plaza systems with VB20A. Customers were asked to install an updated software patch and instructed to share the notification with all users of the affected product. Customers with questions should call Siemens Customer Care Centre at (866)823-9702. For further questions, please call (610) 448-6461.
- Quantity
- 92
- Distribution
- USA (nationwide)
- Lot, serial or model codes
- All Serial Numbers
- 510(k) numbers
- ["K132532"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28