Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 17, 2019
Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.
Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of th…
Elekta Limited recalled Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using… - a moderate-severity action.
Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using… was recalled by Elekta Limited in April 17, 2019. Reason: Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acqu…. Check the official notice for the remedy. Verify recall #Z-1109-2019 with the FDA Devices before acting.
The recall
Elekta Limited issued this moderate-severity FDA Devices recall-Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acqu….
- Moderate
- severity level
- 12 units
- affected scope
- Class II
- classification
- April 17, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1109-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1109-2019) was formally reported on April 17, 2019, with the manufacturer initiating the action on March 12, 2019. 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 12 units.
The documented reason for this recall is: Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion … Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the states of TX, NY, WI, and Denmark, Germany, Italy, Netherlands, Sweden, 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
12 units
Related Recalls
6
6 from same agency
Product description
Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.
Reason for recall
Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are based on data acquired around full expiration. 2) The display of the images in the Elekta Unity Application software does not provide information about the protocol used to acquire the image eg. with or without respiratory triggering. Users must select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1109-2019 |
| Date reported | April 17, 2019 |
| Date initiated | March 12, 2019 |
| Recalling firm | Elekta Limited |
| Firm location | Crawley, N/A |
| Affected scope | 12 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of TX, NY, WI, and Denmark, Germany, Italy, Netherlands, Sweden, 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-1109-2019) 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, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.. Recalled by Elekta Limited. Units affected: 12 units.
Why was this product recalled? ▼
Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are based on data acquired around full expiration. 2) The display of the images in the Elekta Unity Application software does not provide information about the protocol used to acquire the image eg. with or without respiratory triggering. Users must select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 17, 2019. Severity: Moderate. Recall number: Z-1109-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide in the states of TX, NY, WI, and Denmark, Germany, Italy, Netherlands, Sweden, United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1109-2019) 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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Compare this recall with FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access… →
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 April 17, 2019. 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.