Recall Z-2553-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.
| Date | Aug 26, 2014 (initiated Jul 16, 2014) |
| Status | Terminated |
| Reason | The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator. |
| Root cause | Device Design |
| Action | Siemens notified end users of a potential safety issue with the Reagent Lid hinge on the Dimension EXL instrument via an Urgent Medical Device Correction letter, dated July 2014. The letter indicated Customer Service Engineers will inspect and adjust the tension on the reagent lid hinges during every visit and replace hinges which no longer properly adjust. Users were urged to use caution when the Reagent Lid is open and notify Siemens the Reagent Lid is shifting down. |
| Quantity | 2757 |
| Distribution | Nationwide and internationally, including Canada and Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130276 | DIMENSION EXL WITH LM SYSTEM Siemens Healthcare Diagnostics, Inc., Mar 22, 2013 |