FDA Medical Device Recalls (openFDA)
Covidien LP (formerly Nellcor Puritan Bennett Inc.): OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
- Recall number
- Z-2268-2015
- Recalling firm
- Covidien LP (formerly Nellcor Puritan Bennett Inc.)
- Product
- OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
- Status
- Terminated
- Initiated
- 2015-06-29
- Posted
- 2015-07-27
- Terminated
- 2017-11-03
- Reason
- Potential missing segments on the display that can result in misinterpretation of data.
- Root cause
- Device Design
- Action
- Metronic sent an Urgent Medical Device Correction letter dated June 29, 2015 to affected customers. The letter identified the adfected product, problem and actions to be taked. Customers where instructed to return the attached verification form. For questions contact your Medtronic representative.
- Quantity
- 105,831 units
- Distribution
- Worldwide Distribution - US Nationwide including Canada.
- Lot, serial or model codes
- All Lots, Product code N560
- 510(k) numbers
- ["K123581"]
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 2936999
- Firm city
- Boulder
- Firm state
- CO
- 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