FDA Device

Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical

Hazard

Handle Cracking - Cracks in the handle will lead to disconnection of the handle from the monitor, causing the monitor to fall.

What You Should Do

Remedy

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.

Products

Capnostream20 Monitor with Nellcor Pulse Oximetry Module--Part Number: CS 08657- Oridion Medical
Brand
Oridion Capnography Inc
UPC
Serial Numbers: B200001085 B200001254 B200001163 B200001153 B200001150 B200001135 B200001133 B200001086 B200001105 B200001104 B200001103 B200001102 B200001101 B200001325 B200001258 B200001272 B200001275 B200001289 B200001290 B200001291 B200001323

Units Affected

21