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FDA DevicesClass II

RayCare 2024A SP1. Oncology Information Systems.

Published: July 8, 2026Recall ID: Z-2646-2026Category: Medical DevicesCountry: United States
US
Medical DeviceFDA DevicesUSUS

RayCare 2024A SP1. Oncology Information Systems.

Recalling Firm: RAYSEARCH LABORATORIES AB

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Reason for Recall / Hazard

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.

Product Description & Identification

RayCare 2024A SP1. Oncology Information Systems.

Additional Source Details

FieldValue
CityStockholm
StateN/A
Event id99141
Address 1Eugeniavagen 18c
Address 2N/A
Code infoSoftware Version 8.0.1.60193, UDI 0735000201083920240906, Expiration Date: 2030-01-24
Postal codeN/A
Report date20260708
Product typeDevices
Product quantity3 units
Reason for recallBeam 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.
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260520
Initial firm notificationN/A
Center classification date20260701

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Inspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.

2Isolate & Discontinue Use

Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought RayCare 2024A SP1. Oncology Information Systems.?

Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Overview

  • Recalling FirmRAYSEARCH LABORATORIES AB
  • StatusOngoing
  • Risk LevelClass II
  • DistributionWorldwide - US Nationwide distribution.
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

📢 Share Warning

Alert family and friends to keep them safe. Copy this quick alert message:

🚨 SAFETY ALERT: RAYSEARCH LABORATORIES AB - RayCare 2024A SP1. Oncology Information Systems.

Check if your household is affected:
https://therecallfile.com/recalls/raycare-2024a-sp1-oncology-information-systems/FDA-Z-2646-2026
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