Device product
Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex¿ reagent cartridges, allowing the Dimension¿ system to process samples without interruption.
Z-0458-2016
Product summary
- Event
- Event 72738
- Status
- Terminated
- Classification
- Class II
- Quantity
- 106
- Official record key
device-enforcement:Z-0458-2016
Official wording
Reason: 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.
Code information: Dimension EXL with LM Catalog Numbers 778021.911 (Domestic)/ 778021.931 (Intl). All serial numbers.
Distribution pattern: 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, ME, VT, CT, NC and the countries of Canada and Mexico.
Derived failure modes
-
Unknown
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.