Recall Z-0178-2008 ยท DQA Oximeter
Oridion Capnography Inc
Capnostream20 Monitor with Masimo Pulse Oximetry Module - Part Number: CS 08659 - Oridion Medical
| Date | Nov 28, 2007 (initiated Jul 28, 2007) |
| Status | Terminated |
| Reason | Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall. |
| Root cause | Process design |
| Action | Oridion sent Dear Customer letters dated, August 21, 2007, informing users that a new monitor with the improved handle will be shipped by August 31, 2007. |
| Quantity | 6 |
| Distribution | Nationwide Distribution- including states of AZ, CA, FL, MA, MO, OH, TX, WA, and WI, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060065 | CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR Oridion Capnography, Inc., May 4, 2006 |