Dimension Thermal Chamber Motor Cable located in the following models
Medical device recall Z-0409-2019. Published in FDA’s Enforcement Report on Nov 14, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 14, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 277 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
277 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model/UDI: 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…
Every code shown here, 2,000 characters
Model/UDI: 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 Serial Numbers: Serial Numbers to be Inspected 221106 973106 223948-X 224328-AX 972332W-AX 2004070479 2004071143 2004071701 2004072659 2004072983 2001082078 2004080191 2004080512 2004081060 2004081428 2004081859 2004082188 2004082216 2004082330 2004083044 2001070108W 2004070588 2004070601 2004071727 2004073029 2004080889 2004080423 2004081647 2004081901 2004082008 2004082292 2004082379 2004082497 2004082823 2004083030 972004-X 221635-AX 220101-AX 220606-AX 220705-AX 220719-AX 220960-AX 222144-AX 222916-AX 223104-AX 223113-AX 223122-AX 972359W-AX 2001080164W 2001081187 2001081262 2004071443 2001081370W 2001081491 2004080946 2004081615 2004081660 2004081774 2004081828 2004082208 2004082330 973091W-AX 2001080169 2001081363 2001081485 971958W-X 972295W-AX 2001072014 12251163 12251392 12251525 12251745 12251789 12251798 12251895 12252027 12252285 12252523 12252560 12252821 DR250141 DR251512 12251570 12251874 12251902 12251969 12252078 12252097…
FDA’s list runs to 3,380 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 28, 2018.
- FDA classified it on Nov 8, 2018.
- FDA’s Enforcement Report published it on Nov 14, 2018.
- FDA terminated it on Jun 17, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Healthcare Diagnostics, Inc., of Newark, DE.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,380 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.