Class II — Siemens Healthcare Diagnostics, Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| 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 Refurb… |
| Quantity | 277 units |
| 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. |
| Initiated | 2018-09-28 |
| Classified | 2018-11-08 |
| Terminated | 2020-06-17 |
| Recall number | Z-0409-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc. (Z-0409-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81278/
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