CLASS II ONGOING Device recall · Reported 14 Jun 2023 · FDA Enforcement Report

Unity Image-Guided Radiation Therapy System recalled by Elekta

Elekta is recalling Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil, distributed nationwide in the US. The recall was initiated on 6 Apr 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 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

Quantity recalled18 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1675-2023
FDA event ID: 92053
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Ongoing
Recall initiated: 6 Apr 2023
FDA classified: 2 Jun 2023
Reported: 14 Jun 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Apr 2023	Recall initiated by company
2 Jun 2023	Classified by FDA	+57 days
14 Jun 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.

Product as listed by the FDA

Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.

Where it was distributed

US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX.

Nationwide Florida Iowa Kansas Louisiana Michigan New Jersey New Mexico New York Oklahoma Pennsylvania Tennessee Texas Wisconsin

Questions about this recall

Is Unity Image-Guided Radiation Therapy System containing an MR gradient coil recalled?

Yes. Elekta recalled Unity Image-Guided Radiation Therapy System containing an MR gradient coil on 6 Apr 2023. The recall is Class II and its status is Ongoing. Recall number Z-1675-2023.

Why was it recalled?

There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.

Which lots 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

Where was it sold?

US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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