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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/Monitoring Devices

RAYSEARCH LABORATORIES AB: RayCare Oncology Software Recalled for Missing Medication Allergy Warnings

Agency Publication Date: August 25, 2023
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Summary

RaySearch Laboratories is recalling certain versions of its RayCare oncology information system software, including versions 5A, 5B, and 6A, due to a software defect that prevents medication allergy warnings from appearing. This oncology information system is used in clinical settings to manage patient treatment plans and scheduling. One installation is affected by this recall, which was initiated after it was discovered that clinicians may not be notified of a patient's drug allergies during the planning or treatment process. Consumers and healthcare providers should contact the manufacturer or their healthcare facility's IT department to ensure the software has been updated.

Risk

The software may fail to display critical allergy warnings for specific medication substances or drug ingredients. If a clinician is unaware of a patient's allergy because the warning did not appear, they may inadvertently prescribe or administer a medication that causes a serious allergic reaction.

What You Should Do

  1. Identify if your facility is using RayCare software versions 5A (5.0.0.60390), 5A SP1 (5.0.1.60052), 5B SP1 (5.1.1.60246), 5B SP2 (5.1.2.60028), 5B SP3 (5.1.3.60023), or 6A (6.0.0.60553).
  2. Verify the software version and build number by checking the 'About' section within the RayCare application or contacting your clinical technical support team.
  3. If you are using an affected version, contact RaySearch Laboratories AB immediately for instructions on receiving the necessary service packs or software updates to resolve the display issue.
  4. Clinicians should manually verify patient allergy information in the patient's primary medical record before prescribing or administering medications until the software fix is confirmed.
  5. Contact RaySearch Laboratories AB at their headquarters in Stockholm, Sweden, via the contact information provided in your service agreement or by visiting their website.
  6. For additional questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Software update/Service pack

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

Affected Products

Product: RayCare 5A (build 5.0.0.60390)
Model / REF:
5.0.0
Lot Numbers:
UDI-DI: 0735000201039620210524
Product: RayCare 5A SP1 (build 5.0.1.60052)
Model / REF:
5.0.1
Lot Numbers:
UDI-DI: 0735000201046420220305
Product: RayCare 5B SP1 (build 5.1.1.60246)
Model / REF:
5.1.1
Lot Numbers:
UDI-DI: 0735000201053220220316
Product: RayCare 5B SP2 (build 5.1.2.60028)
Model / REF:
5.1.2
Lot Numbers:
UDI-DI: 0735000201062420220613
Product: RayCare 5B SP3 (build 5.1.3.60023)
Model / REF:
5.1.3
Lot Numbers:
UDI-DI: 0735000201069320221027
Product: RayCare 6A (build 6.0.0.60553)
Model / REF:
6.0.0
Lot Numbers:
UDI-DI: 0735000201056320220617

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92777
Status: Active
Manufacturer: RAYSEARCH LABORATORIES AB
Sold By: Direct Sales
Manufactured In: Sweden
Units Affected: 1 install
Distributed To: 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.