FDA-Device2024-07-10Class II
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Abbott Medical
Hazard
Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy.
Sold states
US: Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NE, NH, NJ, NY, OH OK, OR, PA, SC, SD, TX, UT, WI, WV.
Affected count
302 units
Manufactured in
6901 Preston Rd, N/A, Plano, TX, United States
Products
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2265-2024Don't want to check this manually?
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