Class II — Carl Zeiss Meditec AG
| Recalling firm | Carl Zeiss Meditec AG (Jena) |
|---|---|
| Registered facility | View this company's 13 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The device had an incorrect printed calibration value on the calibration certificate. |
| 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 |
| Quantity | 9 devices |
| Distribution | Nationwide Distribution including AZ, CA, CT, DC, FL, GA, OH, and PA. |
| Initiated | 2017-08-30 |
| Classified | 2017-10-02 |
| Terminated | 2018-01-24 |
| Recall number | Z-0001-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Carl Zeiss Meditec AG (Z-0001-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/78082/
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