The Recall Desk
HighFDA (Devices)·Z-0409-2019·Announced 2018-11-14

Siemens Dimension Thermal Chamber Motor Cable Recall for Insulation Defect

Siemens is recalling 277 Dimension thermal chamber motor cables worldwide due to single insulation instead of required double insulation, posing a potential electrical shock risk.

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 is classified as FDA Class II. The hazard is a potential electrical shock, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 277 units of the Dimension Thermal Chamber Motor Cable. The recall affects multiple models of Dimension instruments, including the EXL 200, EXL with LM, RxL Max, and Xpand Plus series, as well as their refurbished and international variants. The specific defect involves electrical cables that have single insulation rather than the required double insulation.

The hazard associated with this defect is a potential electrical shock. The source text notes that there is no exposed current due to the single insulation that could result in this potential shock. The affected units were distributed worldwide, including in the United States and numerous international markets such as Canada, Australia, and various countries in Europe, Asia, and South America.

Consumers and healthcare facilities should identify the affected units by checking the model/UDI numbers and serial numbers listed in the official recall documentation. Siemens is the recalling firm responsible for the corrective action. Users should contact Siemens Healthcare Diagnostics for instructions on how to proceed with the recall.

The recalled product

Product
Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿ EXL with LM 00630414593500; Dimension¿ EXL with LM with STM 00630414593593; Dimension¿ RxL Max 00630414949789; Dimension¿ RxL Max HM 006304
Affected units
277

Distribution

Distributed nationwide across the United States.

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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