ModerateClass IITerminated

FDA Devices recall · Reported November 14, 2018

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 0

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on November 14, 2018. Severity: Moderate. Recall number: Z-0409-2019.

Q: Where was the recalled product distributed?

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..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0409-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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 coul…

Recall #: Z-0409-2019
Affected scope: 277 units
Initiated: September 28, 2018

Compiled from official public sources by the editorial team. · Updated July 2026

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Siemens Healthcare Diagnostics, Inc. recalled Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number:… - a moderate-severity action.

Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number:… was recalled by Siemens Healthcare Diagnostics, Inc. in November 14, 2018. Reason: Thermal chamber motors have electrical cables with single insulation rather than the required double insulati…. Check the official notice for the remedy. Verify recall #Z-0409-2019 with the FDA Devices before acting.

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The recall

Siemens Healthcare Diagnostics, Inc. issued this moderate-severity FDA Devices recall-Thermal chamber motors have electrical cables with single insulation rather than the required double insulati….

Moderate
severity level: 277 units
affected scope: Class II
classification: November 14, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0409-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0409-2019) was formally reported on November 14, 2018, with the manufacturer initiating the action on September 28, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Healthcare Diagnostics, Inc. is listed as the recalling firm, operating out of Newark, DE. Federal records list the affected scope as 277 units.

The documented reason for this recall is: 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 data in the federal record shows the product reached: 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 Me…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

277 units

Related Recalls

3 from same agency

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.

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

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0409-2019
Date reported	November 14, 2018
Date initiated	September 28, 2018
Recalling firm	Siemens Healthcare Diagnostics, Inc.
Firm location	Newark, DE
Affected scope	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, P…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

277 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0409-2019) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on November 14, 2018. Severity: Moderate. Recall number: Z-0409-2019.

Where was the recalled product distributed? ▼

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..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0409-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 14, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.