Recall Z-0021-2019 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Oridion Medical 1987 Ltd.
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
| Date | Jul 31, 2018 |
| Status | Terminated |
| Reason | The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off. |
| Root cause | Nonconforming Material/Component |
| Action | Urgent Medical Device Correction notification letters dated 7/31/18 were distributed to customers. The letters included the following instructions for customers: Share this notification with all care environments where the Capnostream" 20 and Capnostream" 20p bedside patient monitors are used, particularly in the areas where nurse call may be enabled (general care floors). If your facility has distributed these bedside patient monitors to other persons or facilities, please promptly forward a copy of this letter to those recipients. Medtronic is recommending continued use of Capnostream" |
| Quantity | 1819 |
| Distribution | The products were distributed US nationwide and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112368 | CAPNOSTREAM20P WITH AI/ODI Oridion Medical 1987 , Ltd., Jul 19, 2012 |