Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 17, 2020
Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monito…
Elekta Limited recalled Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7… - a moderate-severity action.
Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7… was recalled by Elekta Limited in June 17, 2020. Reason: In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a misma…. Check the official notice for the remedy. Verify recall #Z-2297-2020 with the FDA Devices before acting.
The recall
Elekta Limited issued this moderate-severity FDA Devices recall-In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a misma….
- Moderate
- severity level
- 26 units
- affected scope
- Class II
- classification
- June 17, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2297-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2297-2020) was formally reported on June 17, 2020, with the manufacturer initiating the action on May 21, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Elekta Limited is listed as the recalling firm, operating out of Crawley, N/A. Federal records list the affected scope as 26 units.
The documented reason for this recall is: In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure. Distribution data in the federal record shows the product reached: US distribution to IA, NY, PA, TX, WI. International distribution to Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Turkey, United Kingdom.. 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, 6 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
26 units
Related Recalls
6
6 from same agency
Product description
Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
Reason for recall
In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2297-2020 |
| Date reported | June 17, 2020 |
| Date initiated | May 21, 2020 |
| Recalling firm | Elekta Limited |
| Firm location | Crawley, N/A |
| Affected scope | 26 units |
| Distribution | US distribution to IA, NY, PA, TX, WI. International distribution to Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Turkey, United Kingdom. |
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-2297-2020) 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? ▼
Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571. Recalled by Elekta Limited. Units affected: 26 units.
Why was this product recalled? ▼
In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2020. Severity: Moderate. Recall number: Z-2297-2020.
Where was the recalled product distributed? ▼
Distribution: US distribution to IA, NY, PA, TX, WI. International distribution to Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Turkey, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2297-2020) 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 June 17, 2020. 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 August 2026.