CLASS II ONGOING Device recall · Reported 21 Dec 2022 · FDA Enforcement Report
Oncentra Brachy radiation therapy planning system recalled by Elekta
Elekta is recalling Oncentra Brachy radiation therapy planning system, distributed nationwide in the US. The recall was initiated on 5 Dec 2022 and the FDA has classified it as Class II.
Check your package
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-0719-2023
- FDA event ID
- 91224
- Recalling firm
- Elekta, Atlanta, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Dec 2022
- FDA classified
- 15 Dec 2022
- Reported
- 21 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 5 Dec 2022 | Recall initiated by company | |
| 15 Dec 2022 | Classified by FDA | +10 days |
| 21 Dec 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Oncentra Brachy radiation therapy planning system software.
Where it was distributed
Distribution US nationwide, including Puerto Rico. There was no military/government distribution.
Questions about this recall
Why was it recalled?
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
Which lots are affected?
Version 4.0 and above with Applicator Modeling or Implant Modeling; UDI GTIN numbers: 08717213052758, 08717213038660, 08717213020610, 08717213052321, 08717213052314, 08717213052307, 08717213052291, 08717213052246, 08717213052239, 08717213051881, 08717213051843, 08717213051782, 08717213051775, 08717213051294, 08717213020610, 08717213053717, 08717213053700.
Where was it sold?
Distribution US nationwide, including Puerto Rico. There was no military/government distribution.
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 26 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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