Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 3, 2021
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Elekta, Inc. recalled Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283… - a moderate-severity action.
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283… was recalled by Elekta, Inc. in November 3, 2021. Reason: Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoi…. Check the official notice for the remedy. Verify recall #Z-0182-2022 with the FDA Devices before acting.
The recall
Elekta, Inc. issued this moderate-severity FDA Devices recall-Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoi….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- November 3, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0182-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0182-2022) was formally reported on November 3, 2021, with the manufacturer initiating the action on October 13, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Elekta, Inc. is listed as the recalling firm, operating out of Atlanta, GA. Federal records list the affected scope as 1072 devices.
The documented reason for this recall is: Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels. Distribution data in the federal record shows the product reached: Distribution throughout USA OUS distribution including:Algeria, Argentina, Australia, Austria Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil Brunei, Bulgaria, Canada, Chile, China, Colombia, Croatia, …. 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
1072 devices
Related Recalls
6
3 from same agency
Product description
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Reason for recall
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0182-2022 |
| Date reported | November 3, 2021 |
| Date initiated | October 13, 2021 |
| Recalling firm | Elekta, Inc. |
| Firm location | Atlanta, GA |
| Affected scope | 1072 devices |
| Distribution | Distribution throughout USA OUS distribution including:Algeria, Argentina, Australia, Austria Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil Brunei, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republ… |
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-0182-2022) 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 users using version 4.0 and above with Applicator Modeling license 170283-00. Recalled by Elekta, Inc.. Units affected: 1072 devices.
Why was this product recalled? ▼
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 3, 2021. Severity: Moderate. Recall number: Z-0182-2022.
Where was the recalled product distributed? ▼
Distribution: Distribution throughout USA OUS distribution including:Algeria, Argentina, Australia, Austria Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil Brunei, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran (Islamic Republic of), Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0182-2022) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 3, 2021. 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.