- Recalling firm
- RAYSEARCH LABORATORIES AB
- 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.
- Affected products (lot / model / serial)
- Software Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24
- Units affected
- 3 units
- Distribution pattern
- Worldwide - US Nationwide distribution.
- Firm location
- Stockholm, N/A, Sweden
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- N/A
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2646-2026
- Recall initiated
- May 20, 2026
- FDA classification date
- July 1, 2026
- FDA report date
- July 8, 2026
- FDA event ID
- 99141
- Last updated on HTM Vibe
- July 23, 2026