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Recall Observatory FDA recall evidence

Device product

8500M Handheld Pulse Oximeter

Z-1690-2017

September 29, 2016

Class II

Product summary

Firm
Nonin Medical, Inc
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

    reason.no_named_rule · v1.0.0

    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.