Recall Z-0665-05 ยท DQA Oximeter
Nellcor Puritan Bennett
Nellcor brand Pulse Oximeter, model N-395, Made in Ireland; Distributed by Tyco Healthcare Group, LP, 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 | 5,344 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
| K993637 | N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS Nellcor Puritan Bennett, Inc., Nov 24, 1999 |