Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0614-2021 — 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.

U.S. FDA — Device Enforcement · Germany · 2020-08-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0614-2021
Date of alert
2020-08-06
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Carl Zeiss Meditec AG
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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