Recall Z-0614-2021— Carl Zeiss Meditec AG
Class II · Terminated
Class II FDA medical device recall by Carl Zeiss Meditec AG, initiated 2020-08-06, terminated 2024-12-13. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Carl Zeiss Meditec AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-08-06
- Terminated
- 2024-12-13
- Firm location
- Jena, N/A, Germany
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.