Public recall detail

Catalyst Hd and Catalyst+ Hd Systems

2025-10-21

medium
Recall Safety notice
Quick summary

Quick summary: Catalyst Hd and Catalyst+ Hd Systems. Date: 2025-10-21.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Catalyst Hd and Catalyst+ Hd Systems. Date: 2025-10-21.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandC-RAD Positioning AB
ProductCatalyst Hd and Catalyst+ Hd Systems
IssueMedical devices - Performance
Recall classType I
IdentificationRA-78329

Affected products

ProductCatalyst HD
LotAll lots.
ModelSP001-0026
Serial numberAll lots.
DescriptionCatalyst HD
ProductCatalyst+ HD
LotAll lots.
ModelSP003-0002
Serial numberAll lots.
DescriptionCatalyst+ HD

Issue

C-RAD has noted a potential issue affecting the CSRs mode of the Catalyst+ HD and Catalyst HD systems. The issue is that the stated precision of the catalyst system for stereotactic radiosurgery (SRS) treatments cannot be guaranteed for all couch angles and system setups. in certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance. This could in the worstcase result in erroneous dose delivery.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Radiology
CompaniesC-RAD Positioning AB Sjukhusvagen 12k, Uppsala, Sweden, 75309
Recall date2025-10-15
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-78329
Background{}
CompaniesC-RAD Positioning AB Sjukhusvagen 12k, Uppsala, Sweden, 75309
AudiencesHealthcare
Source updated2025-10-21

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

Official source Monitor products Back to recalls

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...