Recall Z-1049-04 ยท DQA Oximeter
Respironics Novametrix, Inc.
Model 509M Pulse Oximetry Interface Module Software versions 2.0 or 2.5
| Date | Jul 20, 2004 (initiated Sep 2, 2002) |
| Status | Terminated |
| Reason | Audio alarm may fail to sound when SpO2 limits drop below the set limits |
| Root cause | Other |
| Action | 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. |
| Quantity | 901 units |
| Distribution | AK, AZ, CA, CT, FL, NY, NM, PA, OK, TX, |
| FDA record | Open on fda.gov |