Recall Z-2182-2012 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, integrated instrument systems that use prepackaged Flex(R) reagent test cartridges to measure a variety of analytes in human body fluids.
| Date | Aug 9, 2012 (initiated Jul 17, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 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, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WI, WV, and WY and the Virgin and Pa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112999 | DIMENSION CLINICAL CHEMISTRY SYSTEM Siemens Healthcare Diagnostics, Nov 22, 2011 |