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.
FDA Recall Z-0665-05 · Posted 2005-03-30
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Recalling FirmNellcor Puritan Bennett
Recall StatusTerminated
Product CodeDQA
Date Initiated2004-10-18
Date Terminated2006-05-15
Product Quantity5,344 units
Reason for Recall
The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
Firm 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.
Root Cause
Other
Distribution Pattern
There are 2,950 Direct US and US territory Customers. Product shave also been distributed to Canada, Europe, Japan, Latin America and Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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