Abbott Medical: Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 302 units Lot/code info: UDI-DI: 05415067047663/ Serial Numbers: 20196493 20196495 20196496 20196497 20196498 20196500 20196502 20196503 20196504 20196505 20196506 20196507 20196508 20196509 20196511 20196512 20196513 20196514 20196515 20196516 20196517 20207397 20207398 20207399 20207400 20207401 20207402 20207403 20207404 20207406 20207407 20207408 20207409 20207410 20207411 20207412 20207413 20207416 20207417 20207419 20207420 20207421 20207422 20207423 20207424 20207425 20207427 20207428 20207429 20207430 20207431 20207432 20207433 20207434 20207435 20207436 20207437 20207438 20207441 20207442 20207443 20207445 20207447 20207448 20207449 20207450 20207451 20207452 20207454 20207455 20207456 20207457 20207458 20207459 20207460 20207461 20207462 20207463 20207465 20207466 20207468 20207469 20207470 20207471 20207473 20207474 20207477 20207478 20207481 20207482 20207483 20207484 20207485 20207486 20207487 20207488 20207489 20207490 20207491 20207494 20207495 20208681 20208682 20208683 20208685 20208687 20208688 20208689 20208690 20208691 20208692 20208693 20208696 20208697 20208698 20208699 20208701 20208703 20208704 20219079 20219080 20219081 20219082 20219083 20219084 20219087 20219088 20219089 20219090 20219092 20219093 20219095 20219096 20219099 20219100 20219101 20219102 20219103 20219104 20219105 20219106 20219107 20219108 20219111 20219114 20219115 20219116 20219117 20219118 20219119 20219120 20219121 20219122 20219123 20219126 20219128 20219129 20219130 20219131 20219132 20219133 20219134 20

UPC codes

05415067047663

Source

Official record: FDA (Device enforcement) ↗

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