OxiMax N-65 Pulse Oximeters Recalled for Display Segment Defects
FDA is recalling OxiMax N-65 handheld pulse oximeters because missing display segments may cause users to misinterpret oxygen saturation and pulse rate data.
What this means for you
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 FDA Class II classification indicates a risk of temporary or medically reversible health consequences. The hazard involves the misinterpretation of medical data, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling OxiMax N-65 Handheld Pulse Oximeters, including models N65, N65-1, N65P, and N65P-1. These devices are used for continuous or spot-check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate. The recall covers 211,426 units distributed worldwide, including the United States and Canada.
The recall is due to a potential defect where segments on the device's display may be missing. This issue can result in the misinterpretation of the data displayed on the oximeter. The affected product codes are N650, N65, N65-1, N65P, and N65P-1.
Users of these devices should contact the recalling firm, Covidien LP (formerly Nellcor Puritan Bennett Inc.), for instructions on how to proceed. The FDA has classified this as a Class II recall, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.
The recalled product
- Product
- OxiMax 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.
- Category
- Medical Device — Pulse Oximeter
- Affected units
- 211,426
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 (5)
- All Lots of Product Code N650
- N65
- N65-1
- N65P
- N65P-1
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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