RegWardenFDA facility compliance records
Company

C-RAD Positioning AB

3 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2020: 1 recalls; 2025: 2 recalls201720182019120202021202220232024220252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-10-09
    Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of t…
  • Class IIOngoing2025-04-22
    Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
  • Class IITerminated2020-08-06
    PC Application Software c4D not changing Site upon synchronization during the Setup workflow step

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “C-RAD Positioning AB — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9096047-c-rad-positioning-ab/

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