FDA recall Z-1731-2024

Product

Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC

Reason for recall

manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel

Distribution

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

Key facts

Status

Ongoing

Initiation date

2024-01-09

Report date

2024-05-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boulder, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1731-2024