OxiMax N-560 Pulse Oximeter. For continuous or spot check… recallZ-2268-2015 · Covidien LP (formerly Nellcor Puritan Bennett Inc.) · initiated Jun 29, 2015
Class II Terminated All recalls posted in July 2015
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 Covidien LP (formerly Nellcor Puritan Bennett Inc.) 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
Potential missing segments on the display that can result in misinterpretation of data.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2268-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 29, 2015
- Posted by the FDA
- Jul 27, 2015
- Recalling firm
- Covidien LP (formerly Nellcor Puritan Bennett Inc.)
- Quantity
- 105,831 units
- Product code
- DQA
- FDA submissions
- K123581
- Distribution
- Worldwide Distribution - US Nationwide including Canada.
Product description
OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
Code information (models, lots, serial numbers)
All Lots, Product code N560
Other devices under the same FDA submission
1 device cleared under K123581 — 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 N600X-1Covidien LP · Oximeter1 death4 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 71583).
- Z-2267-2015 · TerminatedOxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
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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