Raysearch Laboratories Ab: System, Planning, Radiation Therapy Treatment
RayCare 2024A SP1 Recall Summary RayCare 2024A SP1, a radiation therapy planning system used in cancer treatment, is being recalled because of software issues with treatment delivery notes that can result in data loss when notes are modified at the same time or updated during an active treatment session, with users not being alerted to these changes. The recall affects this oncology information system software distributed nationwide across all U.S. states and territories. This is classified as a Class II recall by RayCare's manufacturer, RaySearch Laboratories AB.
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Product
- RayCare 2024A SP1. Oncology Information Systems.
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-20
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/98db30a7-202a-46ba-92d9-f1b362da083a