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Catalyst+ HD SP003-0002Recalls & reported problems

C-Rad Positioning AB · Class 2

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

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K200435); 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.

Recalls naming this device

  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 · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200435. One submission often covers many models, so check the product and lot details in each record.

  • Z-1092-2026 · Oct 9, 2025 · Open, Classified
    Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Descri

Other Accelerator, Linear, Medical devices

All Accelerator, Linear, Medical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.