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Recall Observatory FDA recall evidence

Device product

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

Z-1732-2024

January 09, 2024

Class II

Product summary

Firm
Covidien
Event
Event 93883
Status
Ongoing
Classification
Class II
Quantity
2305 units
Official record key
device-enforcement:Z-1732-2024

Official wording

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

Code information: Lot # 2023-02-22, 2023-04-28, 2023-05-04, 2023-07-20; UDI: 10884521780125

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

    reason.no_named_rule · v1.0.0

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