Elekta Unity Image-Guided Radiation Therapy System recall
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Why was Elekta Unity Image-Guided Radiation Therapy System recalled?
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
- Recalling firm
- Elekta, Inc.
- Quantity
- 18 devices
- Distribution
- US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX.
- Recall date
- June 14, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)