Model 509M Pulse Oximetry Interface Module Software versions 2.0 or 2.5
This recall has been terminated (originally issued July 20, 2004).
- Company
- Respironics Novametrix, Inc.
- Recall Initiated
- September 2, 2002
- Posted
- July 20, 2004
- Terminated
- July 6, 2004
- Recall Number
- Z-1049-04
- Quantity
- 901 units
- Firm Location
- Wallingford, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Audio alarm may fail to sound when SpO2 limits drop below the set limits
Distribution
AK, AZ, CA, CT, FL, NY, NM, PA, OK, TX,
Lot / Code Info
Software versions 2.0 or 2.5
Root Cause
Other
Action Taken
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.