FDA Device

Model 509M Pulse Oximetry Interface Module Software versions 2.0 or 2.5

Hazard

Audio alarm may fail to sound when SpO2 limits drop below the set limits

What You Should Do

Remedy

Respironics notified customers by letter dated 9/3/02 of the problem with the failure of the audible alarm. A correction would require replacement of the speaker. Non-responders were recontacted by second letter on 2/24/2004.

Products

Model 509M Pulse Oximetry Interface Module Software versions 2.0 or 2.5
Brand
Respironics Novametrix, Inc.
UPC
Software versions 2.0 or 2.5

Units Affected

901 units