# FDA recall Z-1597-2021

> **RAYSEARCH LABORATORIES AB** · Class II · device recall initiated 2021-02-22.

## Product

RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B	including some of the Service Packs. Standalone software treatment planning system

## Reason for recall

For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually, in scripting, or as part of the  Automated breast planning feature. In some cases, when merging two beams where the first beam has clinical dose and the second beam has approximate dose, the dose of the resulting beam will be labeled as Clinical, although dose for some of the beam segments is still calculated with the SVD dose engine and it should be labeled Approximate: Mixed dose. The difference between approximate and final Clinical dose is in most cases small, but there can be body sites such as lung where the difference can be significant.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1597-2021
- **Recalling firm:** RAYSEARCH LABORATORIES AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-22
- **Report date:** 2021-05-26
- **Termination date:** 2023-05-01

- **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-1597-2021

## Citation

> AI Analytics. FDA recall Z-1597-2021. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-1597-2021. Source: US FDA. Licensed CC0.

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