Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 17, 2014
TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This ma…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
TomoTherapy Incorporated recalled TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 … - a moderate-severity action.
TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 … was recalled by TomoTherapy Incorporated in December 17, 2014. Reason: Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a …. Check the official notice for the remedy. Verify recall #Z-0507-2015 with the FDA Devices before acting.
The recall
TomoTherapy Incorporated issued this moderate-severity FDA Devices recall-Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a ….
- Moderate
- severity level
- Class II
- classification
- December 17, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0507-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0507-2015) was formally reported on December 17, 2014, with the manufacturer initiating the action on November 21, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. TomoTherapy Incorporated is listed as the recalling firm, operating out of Madison, WI. Federal records list the affected scope as 210 ( 72 USA; 138 OUS ).
The documented reason for this recall is: Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This may result in an incorrect jaw position du… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) included the states of : AL, AZ, AR, CA, FL, GA, IL, IN, KS, ,Y, MD, MN, MO, NE, NM, NY, NC, OK, OR, PA, SD, TN, TX, UT, WA, WV, WI and WY., and the countries of : JAPAN, BELGIU…. 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.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
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.
Affected scope
210 ( 72 USA; 138 OUS )
Related Recalls
6
3 from same agency
Product description
TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
Reason for recall
Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This may result in an incorrect jaw position during treatment, without generating system interruption.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0507-2015 |
| Date reported | December 17, 2014 |
| Date initiated | November 21, 2014 |
| Recalling firm | TomoTherapy Incorporated |
| Firm location | Madison, WI |
| Affected scope | 210 ( 72 USA; 138 OUS ) |
| Distribution | Worldwide Distribution - USA (nationwide) included the states of : AL, AZ, AR, CA, FL, GA, IL, IN, KS, ,Y, MD, MN, MO, NE, NM, NY, NC, OK, OR, PA, SD, TN, TX, UT, WA, WV, WI and WY., and the countries of : JAPAN, BELGIUM, NETHERLANDS, ITAL… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0507-2015) 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? ▼
TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3). Recalled by TomoTherapy Incorporated. Units affected: 210 ( 72 USA; 138 OUS ).
Why was this product recalled? ▼
Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This may result in an incorrect jaw position during treatment, without generating system interruption.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 17, 2014. Severity: Moderate. Recall number: Z-0507-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) included the states of : AL, AZ, AR, CA, FL, GA, IL, IN, KS, ,Y, MD, MN, MO, NE, NM, NY, NC, OK, OR, PA, SD, TN, TX, UT, WA, WV, WI and WY., and the countries of : JAPAN, BELGIUM, NETHERLANDS, ITALY, GERMANY, KOREA, FRANCE, SWITZERLAND, ENGLAND, CANADA, MEXICO, HONG KONG, AUSTRALIA, SRI LANKA, GREECE, CHINA, PHILIPPINES, MARTINIQUE, ROMANIA, SPAIN and TURKEY..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0507-2015) 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 December 17, 2014. 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.