FDA recall Z-2647-2026

RAYSEARCH LABORATORIES AB · Class II · device

Product

RayCare 2024A SP4. Oncology Information Systems.

Reason for recall

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.

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2026-05-20
Report date: 2026-07-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Stockholm, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2647-2026