Catalyst+ recallZ-1858-2025 · C-Rad Positioning AB · initiated Apr 22, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from C-Rad Positioning AB or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
FDA root cause category: Software design
What the company is doing
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 .
Recall details
- Recall number
- Z-1858-2025
- Status
- Open, Classified
- Initiated by the company
- Apr 22, 2025
- Posted by the FDA
- May 28, 2025
- Recalling firm
- C-Rad Positioning AB
- Quantity
- 44 units
- Product code
- IYE
- FDA submissions
- K200435
- 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.
Product description
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- Catalyst SP002C-Rad Positioning AB · Accelerator, Linear, Medical1 recall1 report
- Catalyst+ SP003-0001C-Rad Positioning AB · Accelerator, Linear, Medical1 recall0 reports
- Catalyst+ HD SP003-0002C-Rad Positioning AB · Accelerator, Linear, Medical1 recall0 reports
- Catalyst+ PT SP003-0008C-Rad Positioning AB · Accelerator, Linear, Medical1 recall0 reports
- Catalyst+ PT X4 SP003-0009C-Rad Positioning AB · Accelerator, Linear, Medical1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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