Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 1, 2017
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.
Incorrect source step size may occur in the software plans
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Nucletron Bv recalled Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B… - a moderate-severity action.
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B… was recalled by Nucletron Bv in November 1, 2017. Reason: Incorrect source step size may occur in the software plans. Check the official notice for the remedy. Verify recall #Z-0050-2018 with the FDA Devices before acting.
The recall
Nucletron Bv issued this moderate-severity FDA Devices recall-Incorrect source step size may occur in the software plans.
- Moderate
- severity level
- Class II
- classification
- November 1, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0050-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0050-2018) was formally reported on November 1, 2017, with the manufacturer initiating the action on August 10, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Nucletron Bv is listed as the recalling firm, operating out of Veenendaal, N/A. Federal records list the affected scope as 89 customer sites have the affected software.
The documented reason for this recall is: Incorrect source step size may occur in the software plans Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) to medical facilities, and to the countries of : Canada, Argentina, Australia, Austria Bangladesh, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombi…. 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
89 customer sites have the affected software
Related Recalls
6
3 from same agency
Product description
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.
Reason for recall
Incorrect source step size may occur in the software plans
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0050-2018 |
| Date reported | November 1, 2017 |
| Date initiated | August 10, 2017 |
| Recalling firm | Nucletron Bv |
| Firm location | Veenendaal, N/A |
| Affected scope | 89 customer sites have the affected software |
| Distribution | Worldwide Distribution - USA (nationwide) to medical facilities, and to the countries of : Canada, Argentina, Australia, Austria Bangladesh, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Croatia, Czech Re… |
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-0050-2018) 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? ▼
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.. Recalled by Nucletron Bv. Units affected: 89 customer sites have the affected software.
Why was this product recalled? ▼
Incorrect source step size may occur in the software plans
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 1, 2017. Severity: Moderate. Recall number: Z-0050-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) to medical facilities, and to the countries of : Canada, Argentina, Australia, Austria Bangladesh, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, United Arab Emirates, and Viet Nam. There was no military/government distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0050-2018) 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 1, 2017. 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.