Nellcor brand OxiMax Pulse Oximeter, model number N-595 recallZ-0664-05 · Nellcor Puritan Bennett · initiated Oct 18, 2004
Terminated All recalls posted in March 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nellcor Puritan Bennett or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0664-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 18, 2004
- Posted by the FDA
- Mar 30, 2005
- Recalling firm
- Nellcor Puritan Bennett
- Quantity
- 42,451 units
- Product code
- DQA
- FDA submissions
- K012891
- Distribution
- There are 2,950 Direct US and US territory Customers. Product shave also been distributed to Canada, Europe, Japan, Latin America and Australia.
Product description
Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.
Code information (models, lots, serial numbers)
All units with serial numbers beginning with G01844386.
Other devices under the same FDA submission
27 devices cleared under K012891 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Nellcor MAXNICovidien LP · Oximeter1 death97 reports
- Nellcor MAXFASTCovidien LP · Oximeter61 reports
- Nellcor MAXIICovidien LP · Oximeter1 death36 reports
- Nellcor MAXNCovidien LP · Oximeter1 death34 reports
- Nellcor MAXNJCovidien LP · Oximeter28 reports
- Nellcor D-YSCovidien LP · Oximeter27 reports
- Nellcor MAXACovidien LP · Oximeter19 reports
- Nellcor DS100ACovidien LP · Oximeter15 reports
- Nellcor DOC10Covidien LP · Oximeter1 death13 reports
- Nellcor MAXAJCovidien LP · Oximeter9 reports
- Nellcor MAXFASTICovidien LP · Oximeter8 reports
- Nellcor MAXAICovidien LP · Oximeter8 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 31271).
- Z-0665-05 · TerminatedNellcor 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.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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