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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 an exposed electrical hazard on a medical device, which poses a risk of harm (electric shock) even though no injuries have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics Inc. is recalling 106 units of the Reagent Management System (RMS) Dimension EXL with LM. The recall is due to refrigeration compressors that are missing the safety cover on the electrical termination block. This defect exposes an electrical hazard located directly behind the RMS Waste Container.
The affected units are distributed nationwide in the United States, as well as in Canada and Mexico. The recall includes all serial numbers for catalog numbers 778021.911 (Domestic) and 778021.931 (International). The RMS is a module used with the Dimension clinical chemistry system to store and manage reagent cartridges.
Users of these systems should contact Siemens Healthcare Diagnostics Inc. for instructions on how to resolve the issue. The exposed electrical termination block presents a potential shock hazard to individuals accessing the area behind the waste container.
The recalled product
- 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¿…
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Hazard
- Affected units
- 106
Distribution
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.
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