Device product
8500M Handheld Pulse Oximeter
Z-1690-2017
Product summary
- Event
- Event 75424
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 (11 US; 4 OUS)
- Official record key
device-enforcement:Z-1690-2017
Official wording
Reason: 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.
Code information: 502002091 502002088 502002087 502002083 502002085 502002086 502002081 502002082 502002080 502002079 502002077 502002078 502002089 502002090
Distribution pattern: Distribution in US (MI, NC, OH, NC, VA), and CANADA
Derived failure modes
-
Unknown
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.