[pending] Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-00
Pending LLM rewrite. Source: FDA_DEVICE Z-1858-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
The recalled product
- Product
- 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), Cataly
- Manufacturer
- C-RAD POSITIONING AB
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalyst HD- SP001-0026/UDI: 07350005280024
- Catalyst PT- SP001-0027/UDI: 07350005280024
- Catalyst X4- SP002-0035/UDI: 07350005280024
Distribution
Distributed nationwide across the United States.
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