Z-0614-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 23, 2020
- Initiation Date
- August 6, 2020
- Termination Date
- December 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 132 units
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.
Distribution Pattern
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.
Code Information
Model: VISUREF 150 Catalog Number: 000000-2227-967 Serial Numbers: Pending