# FDA recall Z-0616-2024

> **Landauer** · Class II · device recall initiated 2023-11-15.

## Product

Landauer microSTARii reader, Medical Dosimetry System, Model Numbers:  18000-000/18001-000/18007-000

## Reason for recall

MicroSTARii readers may be contributing to the nanodot dosimeter measurement inaccuracy in two possible ways. The first is related to the interaction of the reader s LED beam profile with the nanoDot dosimeter. The second is debris formation due to drawer actuation, resulting in a change of reader response that may not be detectable unless known dose QCs are being run regularly.

## Distribution

US and Australia, Brazil, Canada, China, France, Germany, India, Japan, Mexico, Rep of Korea, Taiwan, Thailand, Viet Nam

## Key facts

- **Recall number:** Z-0616-2024
- **Recalling firm:** Landauer
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2023-11-15
- **Report date:** 2024-01-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Glenwood, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0616-2024

## Citation

> AI Analytics. FDA recall Z-0616-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0616-2024. Source: US FDA. Licensed CC0.

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