A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594

FDA device recall Z-2427-2024 · posted 2024-07-24 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.

Action taken

Recall notice sent to consignees beginning on 05/14/2024 via mail. Consignees are asked to confirm or revise the MRI eligibility display on the programmer, pass on the notice to all those who need to be aware within your organization and to other organizations on which this action has an impact, and confirm they have read and understand the customer actions within the letter and to return the signed confirmation form back to Medtronic. An UPDATE TO MEDICAL DEVICE CORRECTION RE: A610 Replacement workflow with DBS Pocket Adaptor affecting MRI eligibility display letter dated January 2025 was sent to customers. ***Updated March 2025*** Beginning March 21, 2025, Medtronic began communications that the software and firmware will be made available to customers in the United States and Puerto Rico Customer actions: "Please share this notice with all those who need to be aware of this issue within your organization,or to any organization where the identified clinician tablet(s) have been transferred and maintain acopy of this notice in your records. "Your Medtronic Deep Brain Stimulation (DBS) sales representative will distribute the new tabletand/or assist with installation of the A610 version 5.0 as soon as those are available in your region.If you have any questions, please contact your Medtronic Sales Representative. "Following review of this letter, sign and return the enclosed Confirmation Form via email toneuro.quality@medtronic.com.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MHY

Quantity affected

18,010 units

Distribution

Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Canary Islands, China, Colombia, Costa Rica, Croatia, Czech Republ

Date initiated

2024-05-15

Date posted

2024-07-24

Location

Minneapolis, MN