Z-1133-2021 Class II Terminated
FDA device recall Z-1133-2021 was initiated by Carl Zeiss Meditec AG on December 7, 2020 and is designated Class II. Reason for recall: When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information d… The recall status is terminated (terminated June 24, 2022). Affected quantity: 613 devices.
Recall Details
- Product Type
- Devices
- Report Date
- February 24, 2021
- Initiation Date
- December 7, 2020
- Termination Date
- June 24, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 613 devices
Product Description
Reason for Recall
Distribution Pattern
U.S.: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Austria, Australia, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, United Kingdom, Guatemala, Hong Kong, Indonesia, Ireland, India, Italy, Japan, Kuwait, Malaysia, Netherlands, New Zealand, Philippines, Poland, Portugal, Russia, Sweden, Singapore, Slovakia, Thailand, Taiwan, and South Africa.