OxiMax N-560 Pulse Oximeters Recalled for Display Segment Defects
The FDA is recalling OxiMax N-560 Pulse Oximeters because missing display segments may cause users to misinterpret oxygen saturation and pulse rate data.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves the misinterpretation of critical medical data (oxygen saturation and pulse rate), which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the OxiMax N-560 Pulse Oximeter, manufactured by Covidien LP (formerly Nellcor Puritan Bennett Inc.). The device is used for continuous or spot-check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
The recall is due to a defect where potential missing segments on the display can result in the misinterpretation of data. This issue affects 105,831 units distributed worldwide, including the United States and Canada. The recall covers all lots of the product with code N560.
Users of these devices should stop using them and contact the manufacturer for instructions on repair or replacement. Misinterpretation of vital sign data can lead to incorrect clinical decisions, which is why the FDA has classified this as a Class II recall.
The recalled product
- Product
- OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
- Category
- Medical Device — Pulse Oximeter
- Affected units
- 105,831
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All Lots
- Product code N560
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Covidien LP (formerly Nellcor Puritan Bennett Inc.) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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