Medtronic Neuromodulation: Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.

Is my product affected?

Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.

• UPC 00763000273668

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling the Restore Clinician Programmer Application Software (model A71100, version 1.0.4232) used with Restore Neurostimulators due to a compatibility issue with some legacy clinician programmer software. This incompatibility prevents the programmer from establishing communication with implanted neurostimulators. A total of 2,408 devices have been affected and distributed worldwide, including throughout the United States (including government and military facilities) and in Australia and Singapore.

The recall notice does not specify a remedy or recommend an action for affected consumers to take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Quantity: 2,408 devices Lot/code info: Version 1.0.4232, UDI-DI 00763000273668.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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