Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical chem
FDA device recall Z-2182-2012 · posted 2012-08-09 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Siemens Healthcare Diagnostics has confirmed that partial insertion of the power cord on the Dimension Reagent Management System (RMS) power input module can cause the plug to overheat and potentially create a fire hazard. RMS without a power cord retention clip may be affected.
- Action taken
- Siemens sent an "URGENT FIELD SAFETY NOTICE" dated June 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were asked to complete and return an attached Field Correction Effectiveness Check Form and fax it to (302) 631-8467. Contact Siemens Technical Solutions Center at 800-441-9250 for questions regarding this notice.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 2,554
- Distribution
- Distributed in the US including Washington, DC, Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM
- Date initiated
- 2012-07-17
- Date posted
- 2012-08-09
- Date terminated
- 2014-04-03
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION CLINICAL CHEMISTRY SYSTEM (K112999) | Siemens Healthcare Diagnostics | 2011-11-22 |