Nonin Medical, Inc recalls 8500M Handheld Pulse Oximeter

Recall date

September 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1690-2017

FDA classification

Class II

Brand / firm

Nonin Medical, Inc

Sold / distributed

Distribution in US (MI, NC, OH, NC, VA), and CANADA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

8500M Handheld Pulse Oximeter