# FDA recall Z-0409-2019

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2018-09-28.

## 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	00630414949796;  Dimension¿ RxL Max HM STM	00630414949819;  Dimension¿ Xpand¿ Plus	00630414949833;  Dimension¿ Xpand¿ Plus HM	00630414949840;  Dimension¿ RxL Max Refurbished	00630414592947;  Dimension¿ RxL Max HM Refurbished	00630414592954;  Dimension¿ Xpand¿ Plus Refurbished	00630414592961;  Dimension¿ Xpand¿ Plus HM Refurbished	00630414592978;  Dimension¿ EXL with LM Refurbished	00630414000268;  Dimension¿ 200 Refurbished	00630414010717;;  Dimension¿ RxL Max w/o HM International	00630414949802;  Dimension¿ RxL Max HM International	00630414945477;  Dimension¿ RxL Max HM STM International	00630414949826;  Dimension¿ Xpand Plus w/o HM International	00630414949857;  Dimension¿ Xpand Plus w/HM International	006304149454

## Reason for recall

Thermal chamber motors have electrical cables with single insulation rather than the required double insulation. There is no exposed current due to the single insulation that could result in a potential electrical shock

## Distribution

Worldwide Distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Brazil, Canada, China, Columbia, Croatia, Egypt, France, Germany, Great Britain, Greece, Hungary, India, Italy, Japan, Malaysia Mexico, Netherlands, Poland, Portugal, Russia, Saudi Arabia, Slovenia, South Africa, South Korea, Spain, Tanzania, Thailand, Tunisia, Turkey, and United Arab Emirates.

## Key facts

- **Recall number:** Z-0409-2019
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-09-28
- **Report date:** 2018-11-14
- **Termination date:** 2020-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0409-2019

## Citation

> AI Analytics. FDA recall Z-0409-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0409-2019. Source: US FDA. Licensed CC0.

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