Carl Zeiss INTRABEAM PRS 500 — Class II medical device recall Z-0001-2018
Terminated recall by Carl Zeiss Meditec AG, reported 2017-10-11, distributed nationwide. The device had an incorrect printed calibration value on the calibration certificate.
| Recall number | Z-0001-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carl Zeiss Meditec AG, Oberkochen, N/A, Germany |
| Recall initiated | 2017-08-30 |
| Classified | 2017-10-02 |
| Reported by FDA | 2017-10-11 |
| Terminated | 2018-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 9 devices |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0001-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.