Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.
Reported: January 20, 2021 Initiated: November 12, 2020 #Z-0860-2021
Product Description
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.
Reason for Recall
A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 7960 downloads
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Latin America, Asia Pacific, Japan, China, and European regions.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.. Recalled by Medtronic Neuromodulation. Units affected: 7960 downloads.
Why was this product recalled? ▼
A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 20, 2021. Severity: Moderate. Recall number: Z-0860-2021.
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