FDA Medical devices recall ·
RayCare 2024A SP1. Oncology Information Systems recall
- Recall number
- Z-2646-2026
- Date
- (initiated May 20, 2026)
- Company / brand
- Raysearch Laboratories Ab
Eugeniavagen 18c, Stockholm, N/A, Sweden - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
RayCare 2024A SP1. Oncology Information Systems.
Why was it recalled?
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24
Distribution
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2646-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.