Reported May 15, 2019 · Terminated
Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy…
Elekta Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta Limited · Linac House · Crawley, N/A · N/A
Is this the product you have?
- Elekta Unity systems Product UsageElekta 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
- Lot codes and dates
- Product Code
UNITY SYSTEM/13553-006/600003UNITY SYSTEM/10817-011/600010UNITY SYSTEM/10562-011/600016UNITY SYSTEM/10719-T03001/600013UNITY SYSTEM/30004070-001/600023UNITY SYSTEM/10420-AVL-U/600008UNITY SYSTEM/11014-UMCU-U/600007UNITY SYSTEM/11611-40/600011UNITY SYSTEM/11489-21/600009
- UDI
15365491536549
- Product Code
- Amount recalled
- 9 devices
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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