The Recall Desk
HighFDA (Devices)·Z-1078-2026·Announced 2026-01-21

Oncology information system recalled over a potential for overtreatment

Elekta is recalling a MOSAIQ Oncology Information System with Particle Therapy License because a specific sequence can result in a partial treatment being delivered twice.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states the sequence may result in overtreatment with a partial treatment delivered twice, and no injuries are reported.

Plain-English summary

The MOSAIQ Oncology Information System with Particle Therapy License, license kit 45700000000IQRO, is being recalled by Elekta, Inc.

The record states that using the oncology information system that manages workflow may result in overtreatment if a plan is delivered with the Particle Therapy IHE-RO TDW-II interface, with one field per fraction or a last field partial treatment, and a partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment. In that sequence the treatment unit does not check the meterset value, so the partial treatment is delivered twice.

The record lists 1 unit, covering MOSAIQ v3.10.200 and versions 3.1.1.0 up to and including v3.2.3.1 with Particle Base. Distribution was nationwide in the United States, in Texas. The FDA has classified the action as Class II.

The enforcement record reports no injuries. Sites should follow Elekta's instructions.

The recalled product

Product
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Manufacturer
Elekta, Inc.
Category
Medical Device — Oncology software
Hazard
  • overtreatment
  • software-fault
  • radiotherapy
  • meterset

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • MOSAIQ v 3.10.200
  • 3.1.1.0
  • 3.1.2.0
  • 3.1.3.0
  • 3.1.3.1
  • 3.1.3.2
  • 3.1.3.3
  • 3.1.3.4
  • 3.2.0.0
  • 3.2.1.0
  • 3.2.1.1
  • 3.2.1.2
  • 3.2.1.3
  • 3.2.1.4
  • 3.2.2.0
  • 3.2.2.1
  • 3.2.3.0
  • 3.2.3.1 UDI-DI: 07340201500026
  • 07340201500071

Distribution

Distributed nationwide across the United States.

Related recalls

Same category