FDA Medical Device Recalls (openFDA)
Nellcor Puritan Bennett Inc: Model 740 and 760 series Ventilators.
- Recall number
- Z-0445-05
- Recalling firm
- Nellcor Puritan Bennett Inc
- Product
- Model 740 and 760 series Ventilators.
- Status
- Terminated
- Initiated
- 2004-12-17
- Posted
- 2005-01-28
- Terminated
- 2008-01-23
- Reason
- Capacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss.
- Root cause
- Other
- Action
- 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.
- Quantity
- 13,010 worldwide, 3,948 in USA and territories.
- Distribution
- Worldwide.
- Lot, serial or model codes
- All units ever manufactured. The product may be identified and tracked through serial numbers. This is a tracked device.
- 510(k) numbers
- ["K964540","K984379"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3002658105
- Firm city
- Carlsbad
- 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