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Lower risk Medical device recall · FDA · Published September 12, 2023

RayCare 5B/6A Oncology Software Recall: Document Visibility Issue

RaySearch Laboratories recalls RayCare 5B and 6A software versions where documents in read-only state may not display correctly when opened outside Documents workspace. Affected units include specific build numbers and service packs.

🇺🇸 FDA recall #Z-0206-2024Medical deviceRaySearch Laboratories ›
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Recalling firmRAYSEARCH LABORATORIES ABEugeniavagen 18c · Stockholm, Sweden
✎ GovInfoNow plain-language explainer

RaySearch Laboratories is recalling certain versions of their RayCare 5B and 6A oncology software. The issue means documents in read-only state might not show properly when opened outside the Documents workspace. This could affect clinical workflows and treatment scheduling. Read more at govinfonow.com/recall/57332-raycare-5b-6a-oncology-software-recall-document-visibility-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/57332-raycare-5b-6a-oncology-software-recall-document-visibility-issue · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0206-2024

Cite this page

“RayCare 5B/6A Oncology Software Recall: Document Visibility Issue.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/57332-raycare-5b-6a-oncology-software-recall-document-visibility-issue. Based on FDA recall #Z-0206-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0206-2024%22&limit=1).

RaySearch Laboratories AB voluntarily recalled RayCare 5B and 6A oncology information systems on Sept. 12, 2023, according to the FDA. The recall addresses an issue where values are not visible for documents in a read-only state when opened outside the Documents workspace.

How to tell if you have it

  • RayCare 5B SP1 (build 5.1.1.60246), UDI-DI 0735000201053220220316
  • RayCare 5B SP3 (build 5.1.3.60023), UDI-DI 0735000201069320221027
  • RayCare 6A (build 6.0.0.60553), UDI-DI 0735000201056320220617

The hazard

The FDA said the hazard involves RayCare 5B and 6A, including service packs, where values will not be visible for documents in a read-only state when opened outside the Documents workspace using document fields configured with single- or multi-selectable values.

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 (Nov. 28, 2025), and RayStation Software Version 8.1.0.47 (Aug. 8, 2025).

How to tell if you have this one

Check if your software version matches: RayCare 5B SP1 (5.1.1.60246), RayCare 5B SP3 (5.1.3.60023), or RayCare 6A (6.0.0.60553). The recall includes specific build numbers with unique identifiers.

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

What to do — step by step

  1. Check Software Version

    Identify your software version by checking the build number in the product details.

Where it went and when

Where it was distributed

Distributed in Maryland and Tennessee.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: yesMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: yesTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “MD, TN” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Maryland, Tennessee.

Recall timeline

FDA published this recall 57 days after the firm started it.

1. Firm started the recall: Sep 12, 202312. FDA classified it Class II: Nov 1, 202323. Published in FDA’s Enforcement Report: Nov 8, 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.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

No, this is a low-risk software issue that affects document visibility in specific scenarios. It does not pose a safety hazard.

What should I do if I have this software?

The recall does not require immediate action. You can continue using the software but should check for document visibility issues in read-only states.

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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-0206-2024 (September 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0206-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 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