Z-0613-2021 Class II Terminated
FDA device recall Z-0613-2021 was initiated by Carl Zeiss Meditec AG on August 6, 2020 and is designated Class II. 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 boa… The recall status is terminated (terminated December 13, 2024). Affected quantity: 603 units.
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
- 603 units
Product Description
Reason for Recall
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.