Model 740 and 760 series Ventilators.
FDA device recall Z-0445-05 · posted 2005-01-28 · Terminated
Recall details
- Recalling firm
- Nellcor Puritan Bennett Inc
- Reason for recall
- Capacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss.
- Action taken
- Customers of record will be notified by letter sent FEDEX, a simple test instruction will be included to use to test the performance of the backup alarm.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 13,010 worldwide, 3,948 in USA and territories.
- Distribution
- Worldwide.
- Date initiated
- 2004-12-17
- Date posted
- 2005-01-28
- Date terminated
- 2008-01-23
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM (K984379) | Puritan Bennett Corp. | 1998-12-10 |
| NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM (K964540) | Puritan Bennett Corp. | 1997-11-14 |