FDA Medical Device Recalls (openFDA)
Nellcor Puritan Bennett: Nellcor brand Pulse Oximeter, Model NPB290, MALLINCKRODT, Made in Ireland, Oxismart, Made in Ireland; Distributed by Nellcor Puritan Bennett, Inc. Pleasanton, CA 94588 U.S.A.
- Recall number
- Z-0662-05
- Recalling firm
- Nellcor Puritan Bennett
- Product
- Nellcor brand Pulse Oximeter, Model NPB290, MALLINCKRODT, Made in Ireland, Oxismart, Made in Ireland; Distributed by Nellcor Puritan Bennett, Inc. Pleasanton, CA 94588 U.S.A.
- Status
- Terminated
- Initiated
- 2004-10-18
- Posted
- 2005-03-30
- Terminated
- 2006-05-15
- Reason
- The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
- Root cause
- Other
- Action
- Customers of record were notified of the advisory by letter sent via US Mail on October 18, 2004, via certified mail. A second letter was sent on December 9, 2004, advising customers that upgrades would be available. Upgrades would be available via returns to the firm''s service center, upgrade kits and speaker replacements via self-installation, and a third party service provider.
- Quantity
- 7,814 units
- Distribution
- There are 2,950 Direct US and US territory Customers. Product shave also been distributed to Canada, Europe, Japan, Latin America and Australia.
- Lot, serial or model codes
- All units with serial numbers beginning with G01844386.
- 510(k) numbers
- ["K972837"]
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 2936999
- Firm city
- Pleasanton
- Firm state
- CA
- 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