FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc.: syngo US Workplace Picture Archiving and Communication System, software version 2.0, Siemens Medical Solutions, Inc., Mountain View, CA 94043
- Recall number
- Z-1138-2008
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- syngo US Workplace Picture Archiving and Communication System, software version 2.0, Siemens Medical Solutions, Inc., Mountain View, CA 94043
- Status
- Terminated
- Initiated
- 2007-12-06
- Posted
- 2008-05-20
- Terminated
- 2010-12-20
- Reason
- Inaccurate results: A software bug may cause inaccurate wall motion abnormality scoring results to be displayed.
- Root cause
- Software design
- Action
- Siemens Medical Solutions sent an Urgent Medical Device Notification letter, dated November 2007, to its consignees. The letter described action required by users, and that Siemens will contact the user with a new software version correcting this error. A field correction to update software is planned to be underway, designated to start on 12/21/2007, and the correction is expected to be completed within 45 days.
- Quantity
- 17 units
- Distribution
- Worldwide Distribution: South Korea, Malaysia, Lithuania and China, and 1 unit to New Jersey in the USA.
- Lot, serial or model codes
- Material number: 10035829, serial numbers: 250576, 260044, 260049, 260016, 250533, 250548, 250544, 250545, 250591, 250595, 250617, 700464562, 700465913, 700465914, 250565, 250557, and 250556.
- 510(k) numbers
- ["K060992"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 2936884
- Firm city
- Mountain View
- Firm state
- CA
- 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