The Recall Desk

FDA (Devices) recall action 72738

Siemens Healthcare Diagnostics Inc. recalled 4 products on 2015-12-30

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2015-12-30
Critical
0
Units
264

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2015-12-30

    Siemens Reagent Management System Recalled for Electrical Hazard

    Siemens is recalling Reagent Management System (RMS) modules for the Dimension RxL Max clinical chemistry system because some units have missing safety covers on electrical termination blocks.

    Product
    Reagent Management System (RMS) Dimension RxL Max w/o HM 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¿…
    Category
    Distribution
    43 states
  • HighFDA (Devices)··2015-12-30

    Siemens Reagent Management System Recalled for Electrical Safety Hazard

    Siemens is recalling 151 Reagent Management System units because missing safety covers expose electrical termination blocks, creating a shock hazard.

    Product
    Reagent Management System (RMS) Dimension RxL Max HM STM 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¿…
    Category
    Distribution
    43 states
  • HighFDA (Devices)··2015-12-30

    Siemens Reagent Management System Recalled for Electrical Hazard

    Siemens is recalling 106 Reagent Management System units because a missing safety cover exposes an electrical hazard on the compressor.

    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¿…
    Category
    Distribution
    43 states
  • HighFDA (Devices)··2015-12-30

    Siemens Reagent Management System Recalled for Electrical Hazard

    Siemens is recalling four Reagent Management System units because a missing safety cover exposes an electrical termination block, creating a shock hazard.

    Product
    Reagent Management System (RMS) Dimension EXL with LM STM 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¿…
    Category
    Distribution
    43 states