Recall record at a glance
| Official record | Z-0409-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Report date | Nov 14, 2018 |
| Recall initiation date | Sep 28, 2018 |
| Quantity | 277 units |
| Location | Newark, DE, United States |
Official product description
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.
Why the product was recalled
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 information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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