Device product
OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
Z-2268-2015
Product summary
- Event
- Event 71583
- Status
- Terminated
- Classification
- Class II
- Quantity
- 105,831 units
- Official record key
device-enforcement:Z-2268-2015
Official wording
Reason: Potential missing segments on the display that can result in misinterpretation of data.
Code information: All Lots, Product code N560
Distribution pattern: Worldwide Distribution - US Nationwide including Canada.
Derived failure modes
-
Unknown
Potential missing segments on the display that can result in misinterpretation of data.