Recall Z-1858-2021 ยท CEM Electrode, Ion Specific, Potassium
Radiometer Medical ApS
E3800 PC Units (spare parts)
| Date | Apr 14, 2021 |
| Status | Open, Classified |
| Reason | Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. |
| Root cause | Device Design |
| Action | On 04/14/2021, the firm initially sent an "Urgent: Medical Device Recall" Letter via email with a follow-up hardcopy via FedEx 2nd Day to customers inform them the Recalling Firm has become aware of a potential for the analyzers internal clocks may become incorrect. For analyzers which do not have an internal battery installed the incorrect time may be triggered in case power is abruptly removed from the analyzer, by e.g. toggling the power switch on the analyzer itself or at the wall outlet, or a power failure occurs on the mains supply. When the analyzer is switched on again, the analyzers |
| Quantity | Total 965 PC units World-wide (only 35 units in the U.S.) |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of AK, A L, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV. The countries of Italy, Norway, Austr |
| FDA record | Open on fda.gov |