Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 19, 2016
Radiation Therapy Treatment Planning System, Model 5.0
For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be tri…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Raysearch Laboratories Ab recalled Radiation Therapy Treatment Planning System, Model 5.0 - a moderate-severity action.
Radiation Therapy Treatment Planning System, Model 5.0 was recalled by Raysearch Laboratories Ab in October 19, 2016. Reason: For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report m…. Check the official notice for the remedy. Verify recall #Z-0079-2017 with the FDA Devices before acting.
The recall
Raysearch Laboratories Ab issued this moderate-severity FDA Devices recall-For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report m….
- Moderate
- severity level
- 491 units
- affected scope
- Class II
- classification
- October 19, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0079-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0079-2017) was formally reported on October 19, 2016, with the manufacturer initiating the action on May 30, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Raysearch Laboratories Ab is listed as the recalling firm, operating out of Stockholm, N/A. Federal records list the affected scope as 491 units (187 domestically & 304 internationally).
The documented reason for this recall is: For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template wher… Distribution data in the federal record shows the product reached: AZ, CA, FL, MT, NC NY, TX, OH & WA. 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
491 units (187 domestically & 304 internationally)
Related Recalls
6
3 from same agency
Product description
Radiation Therapy Treatment Planning System, Model 5.0
Reason for recall
For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0079-2017 |
| Date reported | October 19, 2016 |
| Date initiated | May 30, 2016 |
| Recalling firm | Raysearch Laboratories Ab |
| Firm location | Stockholm, N/A |
| Affected scope | 491 units (187 domestically & 304 internationally) |
| Distribution | AZ, CA, FL, MT, NC NY, TX, OH & WA |
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-0079-2017) 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? ▼
Radiation Therapy Treatment Planning System, Model 5.0. Recalled by Raysearch Laboratories Ab. Units affected: 491 units (187 domestically & 304 internationally).
Why was this product recalled? ▼
For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 19, 2016. Severity: Moderate. Recall number: Z-0079-2017.
Where was the recalled product distributed? ▼
Distribution: AZ, CA, FL, MT, NC NY, TX, OH & WA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0079-2017) 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 October 19, 2016. 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.