FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.
- Recall number
- Z-0121-2011
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostic devices. The EasyLink is included with the Dimension Vista System (K051087), and may be used with other Siemens analyzers, as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.
- Status
- Terminated
- Initiated
- 2010-07-23
- Posted
- 2010-10-21
- Terminated
- 2013-03-19
- Reason
- the EasyLink QCFIRST custom rule does not operate as intended.
- Root cause
- Other
- Action
- Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice dated July 2010 to all customers that have the EasyLink QCFIRST custom rule installed. This Urgent Field Safety Notice included information on the problem and confirmed that a Siemens representative would contact them to facilitate the removal of the rule from the EasyLink System. For questions contact the Siemens Healthcare Diagnostics Technical Solution Center at 1-800-441-9250.
- Quantity
- 82
- Distribution
- Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MO, MS, NC, NH, NJ, NM, NY, OH, OR, PA, TX, VA, WA, WI, and WY and the country of Canada.
- Lot, serial or model codes
- Part # 1000034805
- 510(k) numbers
- ["K051087"]
- PMA numbers
- not on file
- Product code
- JJE
- 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