RayCare 4.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07350002010341), received between Mar 6, 2023 and Mar 7, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (4 reports).

5 other recalls cover devices cleared under the same FDA submission (K200487); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2023Computer Software Problem; Computer Software Problem

  A SOFTWARE MALFUNCTION WAS DETECTED BY A CUSTOMER PRIOR TO TREATMENT. NO PATIENTS WERE AFFECTED. THE FIRST TREATMENT FRACTION HAD BEEN PERFORMED AND WAS TO BE REVIEWED IN OIR. THERE WAS AN ERROR MESSAGE SAYING THAT THE REVIEW FILES WERE NOT AVAILABLE. USER CALLED SUPPORT. IT WAS VERIFIED IN RAYCARE PACS THAT DATA WAS INDEED AVAILABLE. THE TREATMENT IMAGE WAS THEN OPENED IN RAYCARE IMAGE VIEWER AND IT WAS NOTICED THAT THE IMAGE REGISTRATION WAS NOT DONE WITH THE PLANNING IMAGE SET. THE REGISTRATION OBJECT USED WAS CORRECT, BUT THE REGISTRATION WAS DONE ON THE WRONG IMAGE SET. THE BUG IS THAT THE SW SELECTS THE FIRST IMAGE SET WITH THE SAME FRAME OF REFERENCE, RATHER THAN SELECTING THE PLANNING IMAGE SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16498408 ↗
• MalfunctionMar 7, 2023Computer Software Problem; Computer Software Problem

  A SOFTWARE MALFUNCTION WAS DETECTED BY A CUSTOMER PRIOR TO TREATMENT. NO PATIENTS WERE AFFECTED. THE FIRST TREATMENT FRACTION HAD BEEN PERFORMED AND WAS TO BE REVIEWED IN OIR. THERE WAS AN ERROR MESSAGE SAYING THAT THE REVIEW FILES WERE NOT AVAILABLE. USER CALLED SUPPORT. IT WAS VERIFIED IN RAYCARE PACS THAT DATA WAS INDEED AVAILABLE. THE TREATMENT IMAGE WAS THEN OPENED IN RAYCARE IMAGE VIEWER AND IT WAS NOTICED THAT THE IMAGE REGISTRATION WAS NOT DONE WITH THE PLANNING IMAGE SET. THE REGISTRATION OBJECT USED WAS CORRECT, BUT THE REGISTRATION WAS DONE ON THE WRONG IMAGE SET. THE BUG IS THAT THE SW SELECTS THE FIRST IMAGE SET WITH THE SAME FRAME OF REFERENCE, RATHER THAN SELECTING THE PLANNING IMAGE SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16498353 ↗
• MalfunctionMar 6, 2023Computer Software Problem; Computer Software Problem

  NO SERIOUS EVENT OCCURRED. NO PATIENTS WERE AFFECTED. A CUSTOMER NOTICED A MALFUNCTION AFTER UPGRADE OF THE SYSTEM. THIS ISSUE WAS FOUND IN THE RAYCARE UPGRADE. MESSAGE BODY FROM PATIENT RELATED MESSAGES CREATED IN RAYCARE 3B, RAYCARE 4A WILL BE LOST WHEN UPGRADING FROM RAYCARE 2 TO RAYCARE 3B OR LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16492263 ↗
• MalfunctionMar 6, 2023Computer Software Problem; Computer Software Problem

  NO SERIOUS EVENT OCCURRED. NO PATIENTS WERE AFFECTED. A CUSTOMER NOTICED A MALFUNCTION AFTER UPGRADE OF THE SYSTEM. THIS ISSUE WAS FOUND IN THE RAYCARE UPGRADE. MESSAGE BODY FROM PATIENT RELATED MESSAGES CREATED IN RAYCARE 3B, RAYCARE 4A WILL BE LOST WHEN UPGRADING FROM RAYCARE 2 TO RAYCARE 3B OR LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16491646 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200487. One submission often covers many models, so check the product and lot details in each record.

• Z-0206-2024 · Sep 12, 2023 · Open, Classified
  RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment manageme
• Z-2464-2023 · Jul 17, 2023 · Open, Classified
  RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical informatio
• Z-2138-2021 · Jun 8, 2021 · Terminated
  RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B and 11A, in combination with RayCare Model Numbers/ UDI: RayStation 9.0 (9.0.0.1
• Z-1281-2021 · Mar 3, 2021 · Open, Classified
  RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering cancer care.
• Z-2899-2020 · Jul 29, 2020 · Open, Classified
  RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology c