Recall Z-1731-2024 ยท MUD Oximeter, Tissue Saturation
Covidien
Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
| Date | Apr 30, 2024 (initiated Jan 9, 2024) |
| Status | Open, Classified |
| Reason | manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel |
| Root cause | Process design |
| Action | On January 9, 2024 Medtronic (parent company of Covidien) issued a Urgent Medical Device Recall notification via UPS. Medtronic asked consignees to take the following action: 1. Quarantine and stop using all product from the affected lots of INVOS" Reusable Sensor Cables PMAC71RSC and PMAC71RIC. " See attachment A for guidance on how to identify affected devices via cable box packaging or cable hang tag. 2. Complete and return Customer Confirmation Form. Complete and return the enclosed Customer Confirmation Form even if you do not have any affected lots remaining. 3. Reach out to Medtronic |
| Quantity | 1122 units |
| 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 R |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211561 | INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as Covidien, LLC, Dec 5, 2021 |