Dimension Thermal Chamber Motor Cable located in the following… — Class II medical device recall Z-0409-2019
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2018-11-14, distributed nationwide. Thermal chamber motors have electrical cables with single insulation rather than the required double insulatio
| Recall number | Z-0409-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2018-09-28 |
| Classified | 2018-11-08 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2020-06-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BR, CA, CN, DE, DZ, EG, ES, FR, GB, GR, HR, HU, IN, IT, JP, KR, MX, MY, NL, PL, PT, RU, SA, SI, TH, TN, TR, ZA |
| Quantity | 277 units |
| UPC / GTIN / UDI-DI | 00630414000268, 00630414010717, 00630414592947, 00630414592954, 00630414592961, 00630414592978, 00630414593500, 00630414593579, 00630414593593, 00630414593609, 00630414945477, 00630414945484, 00630414949789, 00630414949796, 00630414949802, 00630414949819, 00630414949826, 00630414949833, 00630414949840, 00630414949857, 00842768030024, 00842768037214 |
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 00630414945484; Dimension¿ EXL with LM International 00842768030024; Dimension¿ EXL 200 International 00842768037214 Dimension¿ EXL with LM with STM International 00630414593609 The Dimension motor assembly is used in the Dimension Thermal Chamber Fan (ASSY BLOWER SNOUT) and is responsible for the intake and circulation of air inside the "Wok," a chamber within the Dimension instrument which enables greater temperature control of the testing environment.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0409-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.