# FDA recall Z-0001-2018

> **Carl Zeiss Meditec AG** · Class II · device recall initiated 2017-08-30.

## Product

Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500.  The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany.  The INTRABEAM System is indicated for radiation therapy treatments

## Reason for recall

The device had an incorrect printed calibration value on the calibration certificate.

## Distribution

Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA.

## Key facts

- **Recall number:** Z-0001-2018
- **Recalling firm:** Carl Zeiss Meditec AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-30
- **Report date:** 2017-10-11
- **Termination date:** 2018-01-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oberkochen, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2018

## Citation

> AI Analytics. FDA recall Z-0001-2018. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-0001-2018. Source: US FDA. Licensed CC0.

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