Z-2646-2026 Class II Ongoing
FDA device recall Z-2646-2026 was initiated by RAYSEARCH LABORATORIES AB on May 20, 2026 and is designated Class II. 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 not… The recall status is ongoing. Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2026
- Initiation Date
- May 20, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
RayCare 2024A SP1. 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 Pattern
Worldwide - US Nationwide distribution.
Code Information
Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24