Summary
The FDA issued a Class II for RayCare 2024A SP4. Oncology Information Systems. by RAYSEARCH LABORATORIES AB. 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 updat.
Details
Source
Device Recall
External ID
Z-2647-2026
Action Date
2026-07-08
Status
Ongoing
Category
device
Product Description
RayCare 2024A SP4. Oncology Information Systems.
Lot/Code Info: Software Version 8.0.4.60077, UDI 0735000201089120241218, Expiration Date: 2030-01-24.
Quantity Affected: 3 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-20
Company
Stockholm, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 186 device recalls issued in the same week, part of 534 device-related FDA actions this month.
RAYSEARCH LABORATORIES AB has 53 FDA actions in our database, including 53 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (RAYSEARCH LABORATORIES AB) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does RAYSEARCH LABORATORIES AB have FDA actions?
RAYSEARCH LABORATORIES AB has 53 FDA actions in our database, including 53 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2647-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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