Z-2320-2019 Class II Terminated
FDA device recall Z-2320-2019 was initiated by Radiometer America Inc on July 10, 2019 and is designated Class II. Reason for recall: Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting i… The recall status is terminated (terminated June 13, 2022). Affected quantity: 13,042 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2019
- Initiation Date
- July 10, 2019
- Termination Date
- June 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,042 units
Product Description
Reason for Recall
Distribution Pattern
US: AB, AL, AR, BC, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TX, VA, VT, WA, WI, WV OUS: Canada, Netherland, China, Czech Republic, Denmark, Germany, Spain, France, Hugary, , indiat Japan, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland, Brazil, and Mexico