C-RAD POSITIONING AB recalls Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catal…

Software issue with scanning equipment that can results in the filed rotation not being applied correctly.

Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not a component

On April 22, 2025, C-RAD Positioning AB issued a Field Safety Notice to affected consignees via E-Mail. C-RAD asked consignees to take the following actions: 1. As an immediate action, the affected users are recommended to: - Do not use Site Groups for treatment plans containing non-coplanar fields. - Ungroup all existing Site Groups. 2. Ensure that all the staff operating the Catalyst family systems and the c4D software application are aware of this information. 3. All customers are requested to reply to C-RAD using the attached FSN Customer Reply Form .

• FDA enforcement recordOfficial FDA database entry for Z-1858-2025
• FDA 510(k) clearance · K200435The device's official FDA premarket clearance record
• FDA device classification · IYEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.5050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find C-RAD POSITIONING ABSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.