Recall Z-2226-2023— Medtronic Neuromodulation
Class II · Ongoing
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2023-06-21. FDA's recall record names no specific 510(k) clearance for this event. Product: A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application... Reason: When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not available for download..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-06-21
- Firm location
- Minneapolis, MN, United States
Product description
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Reason for recall
When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not available for download.
Data sourced from openFDA. This site is unofficial and independent of the FDA.