Z-2242-2012Class II

EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System...

Name: Z-2242-2012 EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2012-05-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-05-29 / Terminated / root cause: software

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot... on 2012-05-29. FDA classified it as Class II and gives the reason as "When using the EasyLink Quality Control Package the system may not perform as intended for Multi-Rule QC violations [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions send with the Urgent Field...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2242-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-29
Posted: 2012-08-22
Terminated: 2014-04-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. 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 and may be used with other Siemens analyzers as a communications and connectivity workstation for integration with laboratory information system (LIS) networks.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: When using the EasyLink Quality Control Package the system may not perform as intended for Multi-Rule QC violations [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions send with the Urgent Field Safety Notice. When this situation occurs, QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient
Root cause tag: software
FDA root cause: Software design
Action: Siemens sent an "URGENT FIELD SAFETY NOTICE" dated May 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Field Correction Effectiveness Check Form was attached for customers to complete and return via fax to 302-631-8467. Contact Siemens Technical Solutions Center at 800-441-9250 for questions regarding this notice.
Quantity in commerce: 637
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada, France, Germany, Spain, Portugal, Italy, Japan, Norway, Australia, Austria, New Zealand, Belgium, Switzerland, Netherlands, Malaysia, Slovenia, South Korea, Denmark, Saudi Arabia, Slovakia, Taiwan, Philippines, Czech Republic, and Singapore.
Product codes and lots: Part Number: 1000034805, Version 5.0 and Version 5.0 Service Pack 1 through 4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2242-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2242-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-22

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)