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Catalyst SP002Recalls & reported problems

C-Rad Positioning AB · Class 2

All models of Catalyst+ (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07350005280024), 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 this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K113276); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

  1. Apr 22, 2025Class IIOpen, Classified

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

    Z-1858-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Computer Software Problem1
  • Data Problem1
  • Loss of Data1

Patient problems

  • No Consequences Or Impact To Patient1
  • Radiation Underdose1

Recent adverse event reports

The 1 most recent of 1 reports, 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113276. One submission often covers many models, so check the product and lot details in each record.

  • Z-2075-2021 · Aug 6, 2020 · Terminated
    PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0

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Sources and updates

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