Carl Zeiss Meditec AG VISUREF150 REF 2227-967 — Class II medical device recall Z-0614-2021
Terminated recall by Carl Zeiss Meditec AG, reported 2020-12-23, distributed nationwide. Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectivene
| Recall number | Z-0614-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carl Zeiss Meditec AG, Jena, N/A, Germany |
| Recall initiated | 2020-08-06 |
| Classified | 2020-12-16 |
| Reported by FDA | 2020-12-23 |
| Terminated | 2024-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BO, CA, CH, CO, CY, DE, DK, ES, FR, GB, HK, HR, HU, IE, IN, IT, JP, KR, LU, LV, MY, NL, PT, SG, TR, TW, ZA |
| Quantity | 132 units |
| Reason classes | packaging |
| Model numbers | 000000-2227-967, 2227-967 |
Product
Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The results are used to assist the process of prescribing optical aids such as eyeglasses and contact lenses.
Reason for recall
Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety function of the board would be insufficient resulting in an increased leakage of current and potentially cause electrical shocks to the user.
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-0614-2021. 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.