Catalyst Hd and Catalyst+ Hd Systems
Brand(s)
Last updated
Summary
Product
Catalyst Hd and Catalyst+ Hd Systems
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Catalyst HD | All lots. | SP001-0026 |
| Catalyst+ HD | All 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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
C-RAD Positioning AB
Sjukhusvagen 12k, Uppsala, Sweden, 75309
Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Recall date
Identification number
RA-78329
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