Z-2268-2015 Class II Terminated
FDA device recall Z-2268-2015 was initiated by Covidien LP (formerly Nellcor Puritan Bennett Inc.) on June 29, 2015 and is designated Class II. Reason for recall: Potential missing segments on the display that can result in misinterpretation of data. The recall status is terminated (terminated November 3, 2017). Affected quantity: 105,831 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2015
- Initiation Date
- June 29, 2015
- Termination Date
- November 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 105,831 units
Product Description
OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate.
Reason for Recall
Potential missing segments on the display that can result in misinterpretation of data.
Distribution Pattern
Worldwide Distribution - US Nationwide including Canada.
Code Information
All Lots, Product code N560