Recall Z-0662-05 ยท DQA Oximeter
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.
| Date | Mar 30, 2005 (initiated Oct 18, 2004) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972837 | NPB-290 PULSE OXIMETER (NPB-290) Nellcor Puritan Bennett, Inc., Oct 21, 1997 |