Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent Management System (RMS) is a module for
FDA device recall Z-0458-2016 · posted 2015-12-22 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics Inc.
- Reason for recall
- Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container.
- Action taken
- Siemens sent an Urgent Medical Device Correction (UMDC # DI-16-01.A.US) and Urgent Field Safety Notice (UFSN # DI-16-01.A.OUS) letters dated November 2015 to all affected customers. The letters identified the affected product, problem and actions to be taken. For questions contact your local Siemens technical support representative.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 106
- Distribution
- US Nationwide Distribution: FL, NY, SC, TX, LA, AZ, WI, IA, IL, OH, AL, AK, NH, OK, MD, CA, NM, MS, KY, NJ, MN, GA, CO, MA, SD, TN, MO, PA, MT, SC, NE, KS, VA, AL, NV, WY, OR, PR, MO, OK, GU, HI, AR,
- Date initiated
- 2015-11-10
- Date posted
- 2015-12-22
- Date terminated
- 2017-08-23
- Location
- Brookfield, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION EXL WITH LM SYSTEM (K130276) | Siemens Healthcare Diagnostics, Inc. | 2013-03-22 |