Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 15, 2019
Elekta Unity systems 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.
There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.
Elekta Limited recalled Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is … - a moderate-severity action.
Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is … was recalled by Elekta Limited in May 15, 2019. Reason: There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast a…. Check the official notice for the remedy. Verify recall #Z-1297-2019 with the FDA Devices before acting.
The recall
Elekta Limited issued this moderate-severity FDA Devices recall-There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast a….
- Moderate
- severity level
- 9 units
- affected scope
- Class II
- classification
- May 15, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1297-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1297-2019) was formally reported on May 15, 2019, with the manufacturer initiating the action on April 3, 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 9 devices.
The documented reason for this recall is: There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the states of Texas and Wisconsin. Distribution internationally to Denmark, England, Germany, Italy, Netherlands. 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
9 devices
Related Recalls
6
6 from same agency
Product description
Elekta Unity systems 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
There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1297-2019 |
| Date reported | May 15, 2019 |
| Date initiated | April 3, 2019 |
| Recalling firm | Elekta Limited |
| Firm location | Crawley, N/A |
| Affected scope | 9 devices |
| Distribution | Worldwide Distribution - US Nationwide in the states of Texas and Wisconsin. Distribution internationally to Denmark, England, Germany, Italy, Netherlands |
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-1297-2019) 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 systems 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: 9 devices.
Why was this product recalled? ▼
There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 15, 2019. Severity: Moderate. Recall number: Z-1297-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide in the states of Texas and Wisconsin. Distribution internationally to Denmark, England, Germany, Italy, Netherlands.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1297-2019) 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.
FDA Devices Moderate
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Mate…
Boston Scientific Corporation · 2026-07-29
FDA Devices Moderate
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cathe…
Boston Scientific Corporation · 2026-07-29
FDA Devices Moderate
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
AVID Medical, Inc. · 2026-07-29
FDA Devices Moderate
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Penumbra, Inc. · 2026-07-29
FDA Devices Moderate
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Alphatec Spine, Inc. · 2026-07-29
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 May 15, 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.