FDA Device recall Z-0461-2016
Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Di…
- FDA Device
- Class II
- terminated
- Published 2015-12-30
On 2015-12-30 the FDA classified a Class II recall of Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Di… by Siemens Healthcare Diagnostics, citing siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termina….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0461-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-10 |
| Published | 2015-12-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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¿ system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex¿ reagent cartridges, allowing the Dimension¿ system to process samples without interruption.
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.
Identifiers
| code_info | Dimension RXL MAX HM STM Catalog Numbers 752000.941 (Domestic)/752000.951 (Intl). RMS for RxL Catalog Numbers 753000.9…Dimension RXL MAX HM STM Catalog Numbers 752000.941 (Domestic)/752000.951 (Intl). RMS for RxL Catalog Numbers 753000.901 (Domestic)/753000.902 (Intl). All serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0461-2016%22
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