Medical Device Recall: A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081
Medtronic Neuromodulation · May 15, 2024
Reason for Recall
Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
Product Description
A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descriptions: 1. ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR, 2. ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR, 3. INS 37602 Activa SC Neurostimulator, 4. INS 37603 Activa SCx Neurostimulator, 5. INS B35200 DBS PERCEPT PC, 6. INS B35300 PERCEPT RC V1
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 Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Islamic Republic Of, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic Of, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, Uruguay, Viet Nam.
States Affected
NATIONWIDE
Quantity Affected
18,010 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2427-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.