FDAFDA · Food and drugs·Recall number 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.
Published December 23, 2020 · Recall initiated: August 6, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Carl Zeiss Meditec AG
- Distributor
- Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, MI, MN, NC, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TX, UT, VA, WA and WY. The countries of Argentina, Austria, Australia, Belgium, Bolivia, Canada, Colombia, Croatia, Cyprus, Denmark, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Luxembourg, Malaysia, Maldives, Netherlands, Portugal, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.
- Lot
- Model: VISUREF 150 Catalog Number: 000000-2227-967 Serial Numbers: Pending
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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