Recall Monitor
Health ProductsType I recall

Catalyst Hd and Catalyst+ Hd Systems

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Catalyst Hd and Catalyst+ Hd Systems
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type I
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Products

Affected productsLot or serial numberModel or catalogue number
Catalyst HDAll lots.SP001-0026
Catalyst+ HDAll lots.SP003-0002

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.

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