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Lower risk Medical device recall · FDA · Published July 29, 2020

RayCare Software Recalled: Offline Image Review Errors May Occur

RaySearch Laboratories recalls RayCare software versions 2.2.2.30782, 2.2.3.53423, 3.0.1.43597, 3.1.0.60341, and 4.0.0.60621 for potential offline image review errors during use.

🇺🇸 FDA recall #Z-2899-2020Medical deviceRaySearch Laboratories ›
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Recalling firmRAYSEARCH LABORATORIES ABSveavagen 9 · Stockholm, Sweden
✎ GovInfoNow plain-language explainer

What happened, in plain English

RaySearch Laboratories is recalling specific versions of their RayCare software used in oncology care. The software may display an error message when performing offline image reviews, which could affect clinical workflows. This recall does not involve physical products but software versions that need updating. Read more at govinfonow.com/recall/64602-raycare-software-recalled-offline-image-review-errors-may-occur.

Source Summary by GovInfoNow · govinfonow.com/recall/64602-raycare-software-recalled-offline-image-review-errors-may-occur · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2899-2020

Cite this page

“RayCare Software Recalled: Offline Image Review Errors May Occur.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64602-raycare-software-recalled-offline-image-review-errors-may-occur. Based on FDA recall #Z-2899-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2899-2020%22&limit=1).

Why it’s dangerous

When reviewing images offline in RayCare 2C, 3A, or 3B, the software may show an error message saying 'Review files not available.' This could disrupt clinical workflows but does not indicate a physical hazard.

Who’s affected

Oncology care providers using RayCare software versions 2C SP2, 2C SP3, 3A SP1, 3B, and 4A with the listed software versions. Clinicians managing cancer treatment schedules are most at risk.

How to tell if you have this one

Check if you have RayCare software versions 2.2.2.30782, 2.2.3.53423, 3.0.1.43597, 3.1.0.60341, or 4.0.0.60621 installed on your system. The software is used for oncology care workflows and scheduling.

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

What to do — step by step

  1. Update Software

    Install the latest software version from RaySearch Laboratories to resolve the error message issue.

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 including in the state of Tennessee.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 35 days after the firm started it.

1. Firm started the recall: Jul 29, 202012. FDA classified it Class II: Aug 27, 202023. Published in FDA’s Enforcement Report: Sep 2, 202032020
  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-2899-2020 (July 29, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2899-2020 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