Oridion Medical Capnostream20 capnograph/pulse oximeter monitor and monitor with printer. Part numbers CS 08651, CS 0865
FDA device recall Z-2232-2009 · posted 2009-09-21 · Terminated
Recall details
- Recalling firm
- Oridion Medical 1987 Ltd.
- Reason for recall
- 1) The monitor's ability to withstand electrostatic discharge (ESD) to exposed metal connectors on the back of the monitor which may cause the monitor's display to freeze. 2) The unit generates electromagnetic radiation above the limits set by applicable standards for medical devices
- Action taken
- Oridian sent a letter to all its distributors June 25, 2009, instructing them to gather all the units to be exchanged for factory reconditioned units that have the hardware and software enhancements and meet all performance requirements in full.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CCK
- Quantity affected
- 326 units
- Distribution
- Nationwide.
- Date initiated
- 2009-06-30
- Date posted
- 2009-09-21
- Date terminated
- 2010-10-01
- Location
- Jerusalem, Har Hotzvim Industrial Park, Israel
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 |