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
FDA Recall Z-1858-2025 · Posted 2025-05-28
Advertisement
Recalling FirmC-RAD POSITIONING AB
Recall StatusOpen, Classified
Product CodeIYE
Date Initiated2025-04-22
Product Quantity44 units
Reason for Recall
Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
Firm Action
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 .
Root Cause
Software design
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AK, FL, WA, VA, WA, NC, IL, AR, NC and the countries of Germany, Italy, Uzbekistan, South Korea, Vietnam, Austria, Australia, China, Estonia, Belgium, Uzbekistan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement