Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Summary
The FDA issued a Class II for Restore Clinician Programmer Application Software, model number A71100, used wi by Medtronic Neuromodulation. Reason: The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinici.
Details
Source
Device Recall
External ID
Z-2657-2023
Action Date
2023-10-11
Status
Terminated
Category
device
Product Description
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Lot/Code Info: Version 1.0.4232, UDI-DI 00763000273668.
Quantity Affected: 2,408 devices
Reason for Recall
The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators.
Distribution
Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.
Type: Voluntary: Firm initiated
Recall Initiated: 2020-07-17
Company
Minneapolis, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Neuromodulation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Neuromodulation have FDA actions?
Medtronic Neuromodulation has 50 FDA actions in our database, including 49 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2657-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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