Recall Z-2320-2019 ยท CEM Electrode, Ion Specific, Potassium
Radiometer America Inc
ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
| Date | Aug 22, 2019 (initiated Jul 10, 2019) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | On (date), the firm will email a "Urgent Field Safety Notice" to all customers and will follow-up by mailing a copy of the "Urgent Field Safety Notice" to all customers via Federal Express with tracking and proof of delivery. The Urgent Field Safety Notice ask customers to do the following: 1. Check which version of the operating system (OS) is currently installed on your analyzer: o Logon to the analyzer o Touch Menu, Utilities, Temporary shutdown, and then Confirm o During the shutdown process the analyzer displays the version of OS installed " If the OS version is one of the following |
| Quantity | 13,042 units |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092686 | ABL90 FLEX SERIES Radiometer Medical Aps, Aug 6, 2010 |