Catalyst+Recalls & reported problems across all models

We found 2 models of Catalyst+ by C-Rad Positioning AB in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Mar 16, 2020 and Mar 16, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Catalyst+ recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 22, 2025Open, Classified

   Software issue with scanning equipment that can results in the filed rotation not being applied correctly.

   Z-1858-2025 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

Most reported Catalyst+ problems

Catalyst+ models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Catalyst SP002

  Accelerator, Linear, Medical
  1 recall1 report
• Catalyst+ SP003-0001

  Accelerator, Linear, Medical
  1 recall0 reports

Recent Catalyst+ adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2020Computer Software Problem; Loss of Data; Data Problem; Computer Software Problem; Loss of Data; Data Problem

  IN PRESETUP-SETTINGS STATE THE USER IS ABLE TO CROP THE VOLUME OF INTEREST FOR THE CPOSITION REFERENCE TO DESIRED SIZE. THE USER NEEDS TO PRESS SAVE IN ORDER FOR THE NEW CROPPED CPOSITION REFERENCE TO BECOME ACTIVE. IF SAVE IS NOT PRESSED THERE WILL BE NO CHANGE TO THE CPOSITION REFERENCE. WHEN SAVE IS PRESSED A USER DIALOGUE IS PRESENTED "THE EDITED REFERENCE WILL BECOME THE ACTIVE REFERENCE. DO YOU WANT TO CONTINUE YES/NO?" UPON CONFIRMING WITH A YES, THE REFERENCE IS SAVED. IF A NEW FIELD IS SELECTED AT THE LINAC, C4D WILL AUTOMATICALLY ENTER THE PRESETUP STATE AND SHOW THE PRESETUP SCREEN. THE POTENTIAL ISSUE IS IF A NEW FIELD FOR THE SAME PATIENT IS SELECTED WHEN THE USER WAS EDITING A REFERENCE AND PRESSED SAVE BUT DID NOT ACKNOWLEDGE THE CONFIRMATION DIALOGUE. IF THE USER THEN CONFIRMS THE SAVE REFERENCE OPERATION AFTER THE NEW FIELD WAS SELECTED, C4D WILL ASSIGN THE REFERENCE TO THE SITE WHICH THE NEW FIELDS BELONGS TO IF THE PATIENT IS THE SAME. THIS IS AN ISSUE IF THE NEW FIELD BELONGS TO ANOTHER SITE THAN THE FIRST ONE.

  Patient problems: No Consequences Or Impact To Patient; Radiation Underdose

  MAUDE report 9834353 ↗