Medtronic Xomed IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834 recall — FDA Z-2461-2025
Due to out of the box wobble of the driver.
Overview of recall records associated with Medtronic Xomed, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 9, Class I: 4.
Due to out of the box wobble of the driver.
Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead to procedure delay, extubation, and…
Potential for false negative response on the NIM Vital Nerve Monitoring System
Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
As a result of Medtronic's integrated power console (authentication number: 222ACBZX00018000) being used with software version: v2.7.3.0, it was discovered that there was a defect that…
There is potential for multiple issues due to a manufacturing nonconformity.
There was an increase in complaints related to tip breaks and wobble/vibration.
There was an increase in complaints related to tip breaks and wobble/vibration.
There was an increase in complaints related to tip breaks and wobble/vibration.
During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value…
This page summarizes recall records in which the official source identifies Medtronic Xomed, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.