# FDA recall Z-1858-2025

> **C-RAD POSITIONING AB** · Class II · device recall initiated 2025-04-22.

## 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),    Catalyst+ X4, (SPOO3-0009)    Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser  Component: Not a component

## 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.

## Key facts

- **Recall number:** Z-1858-2025
- **Recalling firm:** C-RAD POSITIONING AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-22
- **Report date:** 2025-06-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Uppsala, N/A, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1858-2025

## Citation

> AI Analytics. FDA recall Z-1858-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1858-2025. Source: US FDA. Licensed CC0.

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