Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026
FDA device recall Z-1858-2025 · posted 2025-05-28 · Open, Classified
Recall details
- Recalling firm
- C-RAD POSITIONING AB
- Reason for recall
- Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- IYE
- Quantity affected
- 44 units
- Distribution
- 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, Be
- Date initiated
- 2025-04-22
- Date posted
- 2025-05-28
- Location
- Uppsala, Sweden
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Catalyst+, Catalyst+ HD (K200435) | C-Rad Positioning AB | 2020-05-07 |