# FDA recall Z-1092-2026

> **C-RAD POSITIONING AB** · Class II · device recall initiated 2025-10-09.

## Product

Brand Name: Catalyst+  Product Name: Catalyst, Catalyst+  Model/Catalog Number: SP001-0026, SP003-0002  Software Version: cSRS module in combination with cMotion module  Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser  Component: Not applicable

## Reason for recall

Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance.

## Distribution

The software module cSRS has been installed in 37 countries  Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, CA, CT, FL, MO, NC, NM, NY, OH, OK, OR, PA, TN, TX, VA, and WA. The countries of Argentina, Australia, Austria, Belarus, Belgium, Benin, Canada, China, Colombia, Egypt, El Salvador, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Mexico, Morocco, Netherlands, New Zealand, Norway, Portugal, Romania, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Ukraine, and Vietnam.

## Key facts

- **Recall number:** Z-1092-2026
- **Recalling firm:** C-RAD POSITIONING AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-09
- **Report date:** 2026-01-21

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1092-2026

## Citation

> AI Analytics. FDA recall Z-1092-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1092-2026. Source: US FDA. Licensed CC0.

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