Nellcor brand Pulse Oximeter, model N-395, Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Be
FDA device recall Z-0665-05 · posted 2005-03-30 · Terminated
Recall details
- Recalling firm
- Nellcor Puritan Bennett
- Reason for recall
- The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 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.
- Date initiated
- 2004-10-18
- Date posted
- 2005-03-30
- Date terminated
- 2006-05-15
- Location
- Pleasanton, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS (K993637) | Nellcor Puritan Bennett, Inc. | 1999-11-24 |