FDA-Device2024-05-08Class II
Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
Covidien
Hazard
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
Sold states
US: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI OUS: Australia Austria Belgium Canary Islands Chile Czech Republic Denmark Finland France Germany Guatemala Indonesia Ireland Italy Japan Korea, Republic Of Kuwait Lithuania Mayotte New Zealand Nicaragua Poland Portugal Romania Slovakia Spain Sweden Switzerland Taiwan United Kingdom
Affected count
1122 units
Manufactured in
6135 Gunbarrel Ave, Boulder, CO, United States
Products
Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1731-2024Don't want to check this manually?
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