Device product
ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
Z-2320-2019
Product summary
- Event
- Event 83312
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,042 units
- Official record key
device-enforcement:Z-2320-2019
Official wording
Reason: 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 in delayed medical treatment.
Code information: All lots with the operating system versions - RXPE -UIM2743 v1.3XXXXXX or RXPE-UIM910 v1.3.XXXXXX
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
Derived failure modes
-
Device software or design
software security vulnerabilities with the firm's analyzer operating system, which may cause