Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Model 740 and 760 series Ventilators.

FDA Recall Z-0445-05 · Posted 2005-01-28

Recalling FirmNellcor Puritan Bennett Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2004-12-17
Date Terminated2008-01-23
Product Quantity13,010 worldwide, 3,948 in USA and territories.

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K984379NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEMPuritan Bennett Corp. · 1998-12-10K964540NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEMPuritan Bennett Corp. · 1997-11-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑