Z-2226-2023 Class II Ongoing
FDA device recall Z-2226-2023 was initiated by Medtronic Neuromodulation on June 21, 2023 and is designated Class II. 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 applica… The recall status is ongoing. Affected quantity: 2 clinician tablets.
Recall Details
- Product Type
- Devices
- Report Date
- August 2, 2023
- Initiation Date
- June 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 clinician tablets
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.
Distribution Pattern
International distribution to the countries of Israel and Serbia.
Code Information
Serial numbers NPL3011706 and NPL3016791, UDI-DI 643169738058.