Z-1690-2017 Class II Terminated
FDA device recall Z-1690-2017 was initiated by Nonin Medical, Inc on September 29, 2016 and is designated Class II. Reason for recall: Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct p… The recall status is terminated (terminated March 12, 2018). Affected quantity: 15 (11 US; 4 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2017
- Initiation Date
- September 29, 2016
- Termination Date
- March 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 (11 US; 4 OUS)
Product Description
8500M Handheld Pulse Oximeter
Reason for Recall
Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated memory feature.
Distribution Pattern
Distribution in US (MI, NC, OH, NC, VA), and CANADA
Code Information
502002091 502002088 502002087 502002083 502002085 502002086 502002081 502002082 502002080 502002079 502002077 502002078 502002089 502002090