Capnostream20 Monitor with Masimo Pulse Oximetry Module - Part Number: CS 08659 - Oridion Medical
FDA device recall Z-0178-2008 · posted 2007-11-28 · Terminated
Recall details
- Recalling firm
- Oridion Capnography Inc
- Reason for recall
- Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 6
- Distribution
- Nationwide Distribution- including states of AZ, CA, FL, MA, MO, OH, TX, WA, and WI,
- Date initiated
- 2007-07-28
- Date posted
- 2007-11-28
- Date terminated
- 2008-09-08
- Location
- Needham Heights, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR (K060065) | Oridion Capnography, Inc. | 2006-05-04 |