FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
- Recall number
- Z-1944-2014
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
- Status
- Terminated
- Initiated
- 2014-05-20
- Posted
- 2014-06-30
- Terminated
- 2015-08-10
- Reason
- Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.
- Root cause
- Device Design
- Action
- An urgent medical device correction notice, dated May 20, 2014, was sent to end users to provide instructions to avoid potential risks associated with the software defect, until changes can be made by a Siemens technical representative.
- Quantity
- 336
- Distribution
- Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain.
- Lot, serial or model codes
- syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- 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