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
- Recall Initiated
- April 22, 2025
- Posted
- May 28, 2025
- Recall Number
- Z-1858-2025
- Quantity
- 44 units
Reason for Recall
Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
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, Belgium, Uzbekistan.
Lot / Code Info
All Catalyst products using software Version: c4D 6.5.1 SP2 Catalyst -SP001-0025/UDI: 07350005280024; Catalyst HD- SP001-0026/UDI: 07350005280024; Catalyst PT- SP001-0027/UDI: 07350005280024; Catalyst X4- SP002-0035/UDI: 07350005280024; Catalyst+ - REF: SP003-0001/UDI: 17350005280762 Catalyst+ HD- SP003-0002/UDI: 17350005280779 Catalyst+ PT- SP003-0008/UDI: 17350005280793 Catalyst+ X4 - SP003-0009/UDI: 17350005280809
Root Cause
Software design
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 .