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Lower risk Medical device recall · FDA · Published July 17, 2023

RayCare software versions 5A, 5B, 6A recall: Allergy warnings may not display

RaySearch recalls software versions 5A, 5B, 6A including service packs due to potential failure to show allergy warnings for medication substances. Affected users should contact RaySearch for details.

🇺🇸 FDA recall #Z-2464-2023Medical deviceRaySearch ›
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Recalling firmRAYSEARCH LABORATORIES ABEugeniavagen 18c · Stockholm, Sweden
✎ GovInfoNow plain-language explainer

RaySearch recalls specific software versions used in cancer care systems because they might not show allergy warnings for medications. This could lead to patients receiving drugs they're allergic to. The recall affects healthcare providers using these software versions. Read more at govinfonow.com/recall/57644-raycare-software-versions-5a-5b-6a-recall-allergy-warnings-may.

Source Summary by GovInfoNow · govinfonow.com/recall/57644-raycare-software-versions-5a-5b-6a-recall-allergy-warnings-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2464-2023

Cite this page

“RayCare software versions 5A, 5B, 6A recall: Allergy warnings may not display.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57644-raycare-software-versions-5a-5b-6a-recall-allergy-warnings-may. Based on FDA recall #Z-2464-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2464-2023%22&limit=1).

The FDA announced on July 17, 2023, that RaySearch Laboratories AB is recalling RayCare software versions 5A, 5B, and 6A. The recall addresses a hazard where allergy warnings for medication substances may not display as expected.

How to tell if you have it

  • Brand: RaySearch
  • Product: RayCare software
  • Versions: 5A, 5B, 6A including service packs
  • Model Numbers: 5.0.0, 5.0.1, 5.1.1, 5.1.2, 5.1.3, 6.0.0
  • Distribution: US Nationwide distribution in the state of TN

The hazard

According to the FDA, an issue was found in the software where an allergy warning against a medication substance will not be displayed as expected under certain circumstances.

Context

GovInfoNow's records show RaySearch Laboratories AB has 36 other recalls on record since July 17, 2017. Other recent recalls of similar products include RayCare 2:024A SP1 Oncology Software Data Loss Risk (May 20, 2026), RayStation/RayPlan 10B Software Recall (November 28, 2025), and RayStation Software Version 8.1.0.47 (August 8, 2025). Other recent recalls of similar products include Stryker NICO Myriad Handpieces Recall (October 31, 2025), Stryker NICO BrainPath Shephard's Hook Recall (October 31, 2025), and Philips Brilliance CT 64 Medical Scanner Recall (August 7, 2026).

How to tell if you have this one

Check for software versions 5A, 5B, 6A including service packs with build numbers like 5.0.0.60390, 5.0.1.60052, 5.1.1.60246, etc. The software is used in cancer care systems for scheduling and treatment management.

  • Brand
    RaySearch
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Contact RaySearch

    Reach out to RaySearch Laboratories AB for specific instructions on how to handle the affected software versions.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution in the state of TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 51 days after the firm started it.

1. Firm started the recall: Jul 17, 202312. FDA classified it Class II: Aug 25, 202323. Published in FDA’s Enforcement Report: Sep 6, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2464-2023 (July 17, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2464-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA