RayCare 2024A SP4 Oncology Information Systems Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
RaySearch Laboratories AB is recalling RayCare 2024A SP4 due to potential data loss in beam set delivery notes.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 7, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
RaySearch Laboratories AB initiated a recall of RayCare 2024A SP4 Oncology Information Systems because of beam set delivery note issues with potential data loss if the note is modified simultaneously or updated during a treatment session without notifying the user.
Which Products Are Affected
The recall affects RayCare 2024A SP4 (Software Version 8.0.4.60077, UDI 0735000201089120241218, Expiration Date: 2030-01-24). Three units were distributed nationwide in the US.
What You Should Do
No specific consumer action steps are provided in the recall notice.
Why This Matters
This Class II recall involves a device that may cause temporary or reversible adverse health consequences.
Source
FDA recall number Z-2647-2026, report date 20260708.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (775 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.