Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 29, 2014
XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Elekta, Inc. recalled XiO RTP System The XiO RTP System is used to create treatment plans for any cancer pat… - a moderate-severity action.
XiO RTP System The XiO RTP System is used to create treatment plans for any cancer pat… was recalled by Elekta, Inc. in January 29, 2014. Reason: When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessar…. Check the official notice for the remedy. Verify recall #Z-0780-2014 with the FDA Devices before acting.
The recall
Elekta, Inc. issued this moderate-severity FDA Devices recall-When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessar….
- Moderate
- severity level
- 13 units
- affected scope
- Class II
- classification
- January 29, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0780-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0780-2014) was formally reported on January 29, 2014, with the manufacturer initiating the action on November 25, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Elekta, Inc. is listed as the recalling firm, operating out of Atlanta, GA. Federal records list the affected scope as 13.
The documented reason for this recall is: When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Distribution including the states of IL, IN, LA, NJ, TX, WA and WI., and the countries of Belgium, Germany, Italy and Netherlands.. 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
13
Related Recalls
6
3 from same agency
Product description
XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
Reason for recall
When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0780-2014 |
| Date reported | January 29, 2014 |
| Date initiated | November 25, 2013 |
| Recalling firm | Elekta, Inc. |
| Firm location | Atlanta, GA |
| Affected scope | 13 |
| Distribution | Worldwide Distribution - US Distribution including the states of IL, IN, LA, NJ, TX, WA and WI., and the countries of Belgium, Germany, Italy and Netherlands. |
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-0780-2014) 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? ▼
XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.. Recalled by Elekta, Inc.. Units affected: 13.
Why was this product recalled? ▼
When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2014. Severity: Moderate. Recall number: Z-0780-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Distribution including the states of IL, IN, LA, NJ, TX, WA and WI., and the countries of Belgium, Germany, Italy and Netherlands..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0780-2014) 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 January 29, 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.