CLASS II Device recall · Reported 29 Jan 2014 · FDA Enforcement Report
XiO RTP System The XiO RTP System is used to create recalled by Elekta
Elekta is recalling XiO RTP System The XiO RTP System is used to create treatment plans for any cancer, distributed in 7 states. The recall was initiated on 25 Nov 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0780-2014
- FDA event ID
- 67078
- Recalling firm
- Elekta, Atlanta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Nov 2013
- FDA classified
- 17 Jan 2014
- Reported
- 29 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Nov 2013 | Recall initiated by company | |
| 17 Jan 2014 | Classified by FDA | +53 days |
| 29 Jan 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Is XiO RTP System The XiO RTP System is used to create treatment plans for any cancer recalled?
Yes. Elekta recalled XiO RTP System The XiO RTP System is used to create treatment plans for any cancer on 25 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0780-2014.
Why was it 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 lots are affected?
Model or Catalog No. MUJ; Software Version XiO Versions 4.80 and higher
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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