# FDA recall Z-0732-2022

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2021-12-30.

## Product

RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy.  Software Version:  6.0.0.24 ,  6.1.0.26 ,  6.1.1.2 ,  6.2.0.7 ,  6.3.0.6 ,  7.0.0.19 ,  8.0.0.61 ,  8.0.1.10 ,  8.1.0.47 ,  8.1.1.8 ,  8.1.2.5 ,  9.0.0.113 ,  9.1.0.933 ,  9.2.0.483 .  Including Service Paks:  Product name (build number) UDI-DI  RayStation 6/RayPlan 2 (6.0.0.24) 07350002010013  RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2) 07350002010082  RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7) 07350002010075  RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6) 07350002010242  RayStation/RayPlan 7 (7.0.0.19) 07350002010068  RayStation/RayPlan 8A (8.0.0.61) 07350002010112  RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) 07350002010136  RayStation/RayPlan 8B (8.1.0.47) 07350002010129  RayStation/RayPlan 8B Service Pack 1 (8.1.1.8) 07350002010204  RayStation/RayPlan 8B Service Pack 2 (8.1.2.5) 07350002010235  RayStation/RayPlan 9A (9.0.0.113) 07350002010174  RayStation/RayPlan 9B (9.1.0.933) 0735

## Reason for recall

If a new primary image set is selected while the cine loop is running, the primary image set will be displayed as both primary and secondary image set in all side-by-side views. This will also be true for any new patient or case opened while the cine loop is running

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0732-2022
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-12-30
- **Report date:** 2022-03-16

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0732-2022

## Citation

> AI Analytics. FDA recall Z-0732-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0732-2022. Source: US FDA. Licensed CC0.

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