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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

RAYSEARCH LABORATORIES AB: RayCare Oncology Information Systems Recalled for Hidden Document Data

Agency Publication Date: November 1, 2023
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Summary

RaySearch Laboratories AB has recalled two RayCare oncology information systems (versions 5B and 6A) because certain critical information may not be visible to clinicians. This software defect occurs when document fields with selectable values are viewed in a 'read-only' state outside of the main Documents workspace, causing important data to appear missing. These systems are used to manage cancer treatment planning, scheduling, and clinical workflows. Consumers should contact their healthcare provider or the manufacturer to ensure their software is updated and that patient information is being displayed correctly.

Risk

If clinicians cannot see all the data in a patient's document, it could lead to incorrect medical decisions or delays in cancer treatment. This poses a moderate risk to patient safety as it affects the integrity of clinical information used for oncology care management.

What You Should Do

  1. Identify if your facility is using RayCare software versions 5B SP1 (build 5.1.1.60246), 5B SP3 (build 5.1.3.60023), or 6A (build 6.0.0.60553).
  2. Verify your system by checking the Unique Device Identifier (UDI-DI) codes: 0735000201053220220316 for 5B SP1; 0735000201069320221027 for 5B SP3; or 0735000201056320220617 for 6A.
  3. Be aware that values in document fields configured with single- or multi-selectable values will not be visible when the document is in a read-only state outside the Documents workspace.
  4. Contact your healthcare provider or RaySearch Laboratories AB at their headquarters in Stockholm, Sweden, to discuss software updates or patches that resolve this visibility issue.
  5. For further information or technical questions, contact the FDA medical device hotline at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Software update or manufacturer contact

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: RayCare 5B SP1 (5.1.1.60246)
Model / REF:
RayCare 5B SP1 (5.1.1.60246)
UPC Codes:
0735000201053220220316
Product: RayCare 5B SP3 (5.1.3.60023)
Model / REF:
RayCare 5B SP3 (5.1.3.60023)
UPC Codes:
0735000201069320221027
Product: RayCare 6A (6.0.0.60553)
Model / REF:
RayCare 6A (6.0.0.60553)
UPC Codes:
0735000201056320220617

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93139
Status: Active
Manufacturer: RAYSEARCH LABORATORIES AB
Sold By: RaySearch Laboratories AB
Manufactured In: Sweden
Units Affected: 2 sytems
Distributed To: Maryland, Tennessee

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.