Reported Jun 14, 2023 · Ongoing
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Elekta, Inc.
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, Inc. · 400 Perimeter Center Ter NE Ste 50 · Atlanta, GA · 30346-1227
Is this the product you have?
- Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
- Lot codes and dates
- UDI GTIN 05060191071598
- serial numbers
14117-007/60003410632-010/60003610817-011/60001010905-008/60003711198-010/60004711198-011/60004811830-010/60006411888-004/60007212108-007/60001913371-002/60002113553-006/60000330003193-003/60007413120-017/60007311328-019/60005914232-001/60009512269-004/60010011008-003/60010413212-007/600106
- Amount recalled
- 18 devices
Where it was sold
Why it was recalled
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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