Radiometer Medical ApS Recall 87870
Description: E3800 PC Units (spare parts)
Radiometer Medical ApS Recall 87870 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1858-2021 |
| Event ID | 87870 |
| Event Description | E3800 PC Units (spare parts) |
| Product Type | Devices |
| 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, Austria, Argentina, Bangladesh, Bahrain, Bolivia, Chile, Colombia, Costa Rica, Greece, Ecuador, Israel, Jordan, Kuwait, Niue, Oman, Peru, Philippines, Qatar, Romania, Serbia, Saudi Arabia, United Arab Emirates, Uruguay, Belgium, Netherlands, Luxembourg, China, Croatia, Hungary, Denmark, Iceland, Germany, Spain, India, Japan, United Kingdom, Russia, Australia, New Zealand, Switzerland, France, Czech Republic, Slovakia, South Africa, Poland, Turkey, Georgia, Canada, Sweden, Finland, Kazakhstan, Mexico, South Korea, Singapore, Malaysia, Portugal, Ireland, and Hong Kong. |
| Quantity | Total 965 PC units World-wide (only 35 units in the U.S.) |
| Recall Reason | Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. |
| Device Classification | 20210623 |
| Device Code Info | Part number: 910-414 |
| Center Classification Date | 20210615 |
| Recall Initiation Date | 20210414 |
| Recalling Firm | Radiometer Medical ApS |
| Initial Notification | Letter |
| Similar To |