Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes
FDA device recall Z-2553-2014 · posted 2014-08-26 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 2757
- Distribution
- Nationwide and internationally, including Canada and Mexico
- Date initiated
- 2014-07-16
- Date posted
- 2014-08-26
- Date terminated
- 2014-12-16
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION EXL WITH LM SYSTEM (K130276) | Siemens Healthcare Diagnostics, Inc. | 2013-03-22 |