Reported Dec 23, 2020 · Terminated
Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the…
Carl Zeiss Meditec AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carl Zeiss Meditec AG · Carl-Zeiss-Promenade 10 · Jena, N/A · N/A
Is this the product you have?
- Carl Zeiss Meditec AG
- VISUREF150 REF 2227-967 - Product Usageis 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
- Lot codes and dates
- ModelVISUREF 150
- Catalog Number000000-2227-967
- Serial NumbersPending
- Amount recalled
- 132 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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