FDA-Device2017-04-05Class II
8500M Handheld Pulse Oximeter
Nonin Medical, Inc
Hazard
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.
Sold states
Distribution in US (MI, NC, OH, NC, VA), and CANADA
Affected count
15 (11 US; 4 OUS)
Manufactured in
13700 1st Ave N, Plymouth, MN, United States
Products
8500M Handheld Pulse Oximeter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1690-2017Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief