Model 509M Pulse Oximetry Interface Module Software versions 2.0 or 2.5
FDA device recall Z-1049-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Respironics Novametrix, Inc.
- Reason for recall
- Audio alarm may fail to sound when SpO2 limits drop below the set limits
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 901 units
- Distribution
- AK, AZ, CA, CT, FL, NY, NM, PA, OK, TX,
- Date initiated
- 2002-09-02
- Date posted
- 2004-07-20
- Date terminated
- 2004-07-06
- Location
- Wallingford, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODEL 509M PULSE OXIMETER, MODEL 509M (K032755) | Respironics Novametrix, Inc. | 2004-05-21 |
| MODIFICATION TO MARSPO2, MODEL 2001 (K000794) | Novametrix Medical Systems, Inc. | 2000-04-10 |
| MARSPO2, MODEL 2001 (K993979) | Novametrix Medical Systems, Inc. | 2000-02-22 |