Elekta Unity recallZ-2297-2020 · Elekta Limited · initiated May 21, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Elekta Limited or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Device Design
What the company is doing
Elekta notified customers of the recalls on about 05/21/2020 via "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" letter. Customers were informed that 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. Instructions included that although there is no method to correct the scaling issue for the affected protocols, the device can still be used under two options: 1. Without the use of Motion Monitoring and 2. compensation for intra-fraction motion can be done through the acquisition of a 3D Verification MRI, which is not impacted by the scaling issue. On 08/05/2020, Elekta issued an additional customer notification to provide additional details of the recall status and to clarify and provide a more generic message regarding the recall issue.
Recall details
- Recall number
- Z-2297-2020
- Status
- Terminated
- Initiated by the company
- May 21, 2020
- Posted by the FDA
- Jun 8, 2020
- Recalling firm
- Elekta Limited
- Quantity
- 26 units
- Product code
- IYE
- FDA submissions
- K192482
- 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.
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
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571. UDI Number 05060191071321. Anatomy (Protocol Name): Abdomen (btFFE Cor RealTime, btFFE Cor Sag RealTime, btFFE Cor Sag Tra RealTime, btFFE Fast Sag Cor RealTime, btFFE Sag RealTime); HeadNeck L (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); HeadNeck M (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); Pelvis L (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); Pelvis M (bFFE Cor RealTime, bFFE Cor Sag RealTime, bFFE Cor Sag Tra RealTime, bFFE Sag RealTime, bFFE Sag Tra RealTime); Thorax (btFFE Cor RealTime, btFFE Cor Sag RealTime, btFFE Cor Sag Tra RealTime, btFFE Sag RealTime, btFFE Sag RealTime)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Elekta Unity 1536549Elekta Limited · Accelerator, linear, medical1 recall6 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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