FDA Medical Device Recalls (openFDA)
Respironics Novametrix, Inc.: Model 509M Pulse Oximetry Interface Module Software versions 2.0 or 2.5
- Recall number
- Z-1049-04
- Recalling firm
- Respironics Novametrix, Inc.
- Product
- Model 509M Pulse Oximetry Interface Module Software versions 2.0 or 2.5
- Status
- Terminated
- Initiated
- 2002-09-02
- Posted
- 2004-07-20
- Terminated
- 2004-07-06
- 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,
- Lot, serial or model codes
- Software versions 2.0 or 2.5
- 510(k) numbers
- ["K032755","K993979","K000794"]
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 1219324
- Firm city
- Wallingford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28