Z-2226-2023 Class II Ongoing
FDA device recall Z-2226-2023 was initiated by Medtronic Neuromodulation on Jun 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… The recall status is ongoing. Affected quantity: 2 clinician tablets.
Recall details
- Product Type
- Devices
- Report Date
- Aug 2, 2023
- Initiation Date
- Jun 21, 2023
- 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2226-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026