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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 1
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
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