Device product
Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
Z-1731-2024
Product summary
- Firm
- Covidien
- Event
- Event 93883
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1122 units
- Official record key
device-enforcement:Z-1731-2024
Official wording
Reason: manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
Code information: Lot # 20221220 and 20230721; UDI: 10884521806436
Distribution pattern: 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
Derived failure modes
-
Unknown
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel