Agency classClass IIOur severity:Severe FDA (Devices)·Z-2182-2012·Announced 2012-08-15

Siemens Dimension Reagent Management System Power Cord Recall

Siemens Healthcare Diagnostics is recalling 2,554 Dimension Reagent Management System power cords due to a fire hazard caused by partial cord insertion.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a potential fire hazard, which constitutes a significant injury/property-damage risk under the rubric for a score of 4.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 2,554 units of the Dimension Reagent Management System (RMS) power cord. The affected units have serial numbers ranging from 99060001 to 99062554. These power cords are components for the Siemens Healthcare Diagnostics Dimension clinical chemistry analyzers, which are fully automated, microprocessor-controlled systems used to measure analytes in human body fluids.

The recall was initiated because partial insertion of the power cord into the RMS power input module can cause the plug to overheat, potentially creating a fire hazard. The source text notes that RMS units without a power cord retention clip may be affected.

The affected products were distributed across the United States, including Washington, DC, Puerto Rico, the Virgin and Pacific Islands, and all 50 states. Consumers and healthcare facilities should check their equipment for the affected serial numbers and contact Siemens Healthcare Diagnostics for instructions on how to resolve the issue.

The recalled product

Product: Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, integrated instrument systems that use prepackaged Flex(R) reagent test…
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — Clinical Chemistry Analyzer Component
Hazard: fire
overheating
Affected units: 2,554

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Serial numbers 99060001 - 99062554

Distribution

Distributed in 51 states:

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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Same hazard · fire