FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images.
- Recall number
- Z-0826-2016
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images.
- Status
- Terminated
- Initiated
- 2016-01-29
- Posted
- 2016-02-19
- Terminated
- 2017-02-16
- Reason
- Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients.
- Root cause
- Software design
- Action
- The firm, Siemens Healthcare, sent a "Customer Advisory Notice" dated 1/19/2019 to its customers.The notice described the product, problem and actions to be taken. The customers were instructed to create a new department if immediate resolution is necessary, use workplace for reporting and hand over the customer letter before or during installation of field modification(PSL) distributed with Update Instruction SY013/16P. A software update to resolve reported issues is being released via an Update Instruction SY013/16/P. If you have any questions, contact Regulatory Technical Specialist at 610-448-6478 or email: anastasia.sokolova@siemens.com.
- Quantity
- 151
- Distribution
- US Nationwide Distribution including states of: AL AR AZ CA CO CT DE FL GA IL IN KS LA MA MD MI MN MO NC ND NE NJ NM NY OH OR PA SC TN TX UT VA WA and WI.
- Lot, serial or model codes
- For model #10091673
- 510(k) numbers
- ["K023772","K102150"]
- 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