Stockholm, N/A, Sweden
ELEKTA SOLUTIONS AB recalls
2 recalls recorded since 2018, most recently on 17 September 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 17 September 2025
- Reason
- When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.
- Distribution
- Worldwide - U.S. Nationwide distribution in the state of NM and the countries of Canada, Malta, and South Africa.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0503-2026
- MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500
Terminated Class II Medical devices
- Recall started
- 28 September 2021
- Terminated
- 14 June 2024
- Reason
- There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
- Distribution
- Distribution was to ND and NC. There was no military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0115-2022
- Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.