FDA-Device2024-05-08Class II

Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC

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
2305 units
Manufactured in
6135 Gunbarrel Ave, Boulder, CO, United States
Products
Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1732-2024

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