Elekta, Inc. recalls Elekta Unity Image-Guided Radiation Therapy System containin
See all recalls from Elekta, Inc. →Recalled Product
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Hazard / Issue
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: UDI GTIN 05060191071598, serial numbers: 14117-007/600034, 10632-010/600036, 10817-011/600010, 10905-008/600037, 11198-010/600047, 11198-011/600048, 11830-010/600064, 11888-004/600072, 12108-007/600019, 13371-002/600021, 13553-006/600003, 30003193-003/600074, 13120-017/600073, 11328-019/600059, 14232-001/600095, 12269-004/600100, 11008-003/600104, 13212-007/600106
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for Elekta Unity Image-Guided Radiation →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
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