The Recall Desk
HighFDA (Devices)·Z-0461-2016·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (electrical shock) where no injuries have been reported, fitting the High severity criteria for theoretical hazards.

Plain-English summary

Siemens Healthcare Diagnostics Inc. is recalling 151 units of the Reagent Management System (RMS) for the Dimension RxL Max HM STM clinical chemistry system. The recall is due to a safety defect where the refrigeration compressors are missing the safety cover on the electrical termination block.

The exposed electrical hazard is located directly behind the RMS Waste Container. This defect creates a risk of electrical shock. The affected units were distributed nationwide in the United States, as well as in Canada and Mexico.

Healthcare facilities should stop using the affected RMS modules and contact Siemens Healthcare Diagnostics Inc. for instructions on repair or replacement. The recall includes units with catalog numbers 752000.941, 752000.951, 753000.901, and 753000.902, across all serial numbers.

The recalled product

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¿ sy
Affected units
151

Distribution

Distributed nationwide across the United States.

The notice also names 43 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Siemens Healthcare Diagnostics Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics Inc.

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