Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.
Reason for recall: Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period. Distribution: US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, TX, WA, WI. Quantity: 534 Lot/code info: UDI-DI 00763000930042 Serial Nos/Lots: NPN0076461 NPN0076462 NPN0076465 NPN0076466 NPN0076467 NPN0076468 NPN0076469 NPN0076470 NPN0076471 NPN0076472 NPN0076473 NPN0076474 NPN0076475 NPN0076476 NPN0076477 NPN0076479 NPN0076480 NPN0076482 NPN0076483 NPN0076485 NPN0076486 NPN0076487 NPN0076488 NPN0076489 NPN0076490 NPN0076491 NPN0076492 NPN0076493 NPN0076494 NPN0076495 NPN0076496 NPN0076497 NPN0076498 NPN0076499 NPN0076500 NPN0076501 NPN0076502 NPN0076504 NPN0076505 NPN0076506 NPN0076507 NPN0076508 NPN0076509 NPN0076510 NPN0076511 NPN0076512 NPN0076513 NPN0076514 NPN0076515 NPN0076516 NPN0076517 NPN0076518 NPN0076520 NPN0076522 NPN0076523 NPN0076524 NPN0076525 NPN0076526 NPN0076527 NPN0076528 NPN0076529 NPN0076530 NPN0076531 NPN0076532 NPN0076533 NPN0076534 NPN0076535 NPN0076536 NPN0076537 NPN0076538 NPN0076539 NPN0076540 NPN0076541 NPN0076542 NPN0076543 NPN0076545 NPN0076546 NPN0076548 NPN0076550 NPN0076551 NPN0076552 NPN0076553 NPN0076554 NPN0076555 NPN0076556 NPN0076557 NPN0076558 NPN0076559 NPN0076560 NPN0076561 NPN0076562 NPN0076563 NPN0076564 NPN0076565 NPN0076566 NPN0076567 NPN0076568 NPN0076569 NPN0076570 NPN0076571 NPN0076572 NPN0076573 NPN0076575 NPN0076577 NPN0076578 NPN0076579 NPN0076580 NPN0076581 NPN0076582 NPN0076583 NPN0076584 NPN0076585 NPN0076586 NPN0076587 NPN0076588 NPN0076589 NPN0076590 NPN0076591 NPN0076593 NPN0076594 NPN0076596 NPN0076598 NPN0076599 NPN0076602 NPN0076603 NPN0076605 NPN0076607 NPN0076608 NPN0076609 NPN0076610 NPN0076611 NPN0076612 NPN007661
00763000930042
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.