Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
FDA device recall Z-1731-2024 · posted 2024-04-30 · Open, Classified
Recall details
- Recalling firm
- Covidien
- Reason for recall
- manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
- Action taken
- 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 to obtain RGA # /Returned Goods Authorization number. " Your Medtronic Representative / Medtronic Customer Service at rs.covidienfeedbackcustomerservice@medtronic.com can assist in initiating product return as necessary. 4. Return all product from the affected lots in your possession to Medtronic as described on the Customer Confirmation Form. 5. Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product from the specified lots has been transferred or distributed.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- MUD
- Quantity affected
- 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 Ire
- Date initiated
- 2024-01-09
- Date posted
- 2024-04-30
- Location
- Boulder, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) (K211561) | Covidien, LLC | 2021-12-05 |