Events

Recall of Device Recall Sunrise Brand Zippie Voyage

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sunrise Medical (US) LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66896
  • Event Risk Class
    Class 2
  • Event Number
    Z-0453-2014
  • Event Initiated Date
    2013-11-11
  • Event Date Posted
    2013-12-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-03-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124071
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Wheelchair, mechanical - Product Code IOR
  • Reason
    There is a remote possibility for the plastic latch to deform over the lifetime of use. when this happens there is the possibility for the seat to become dislodged from the base. and when not using the positioning strap, there is a risk that the occupant could slide out of the seat and sustain injury.
  • Action
    Urgent Medical Device Field correction letters were sent to Sunrise Suppliers/Dealers and Zippie Customers on November 2013 by first class mail. Foreign notification was supplied to suppliers and regulatory affairs director in Canada.

Device

Device Recall Sunrise Brand Zippie Voyage
  • Model / Serial
    Serial Numbers: ZV-001563 ,ZV-001672 ,ZV-001691 ,ZV-001737 ,ZV-001740 ,ZV-001423 ,ZV-001537 ,ZV-001557 ,ZV-001604 ,ZV-001746 ,ZV-001749 ,ZV-001761 ,ZV-001669 ,ZV-001682 ,ZV-001722 ,ZV-001755 ,ZV-001711 ,ZV-001415 ,ZV-001634 ,ZV-001716 ,ZV-001615 ,ZV-001521 ,ZV-001589 ,ZV-001617 ,ZV-001618 ,ZV-001627 ,ZV-001683 ,ZV-001702 ,ZV-001763 ,ZV-001773 ,ZV-001491 ,ZV-001531 ,ZV-001534 ,ZV-001562 ,ZV-001560 ,ZV-001569 ,ZV-001575 ,ZV-001720 ,ZV-001772 ,ZV-001635 ,ZV-001659 ,ZV-001777 ,ZV-001712 ,ZV-001487 ,ZV-001526 ,ZV-001574 ,ZV-001759 ,ZV-001595 ,ZV-001555 ,ZV-001603  ,ZV-001775 ,ZV-001520 ,ZV-001485 ,ZV-001519 ,ZV-001460 ,ZV-001687 ,ZV-001515 ,ZV-001614 ,ZV-001465 ,ZV-001742 ,ZV-001767 ,ZV-001685 ,ZV-001628 ,ZV-001785 ,ZV-001407 ,ZV-001408 ,ZV-001507 ,ZV-001658 ,ZV-001663 ,ZV-001511 ,ZV-001532 ,ZV-001545 ,ZV-001778 ,ZV-001568 ,ZV-001585 ,ZV-001607 ,ZV-001631 ,ZV-001629 ,ZV-001650 ,ZV-001654 ,ZV-001675 ,ZV-001717 ,ZV-001769 ,ZV-001430 ,ZV-001570 ,ZV-001559 ,ZV-001475 ,ZV-001488 ,ZV-001489 ,ZV-001490 ,ZV-001542 ,ZV-001578 ,ZV-001583 ,ZV-001656 ,ZV-001728 ,ZV-001714 ,ZV-001652 ,ZV-001653 ,ZV-001536 ,ZV-001676  ,ZV-001355 ,ZV-001366 ,ZV-001483 ,ZV-001594 ,ZV-001701 ,ZV-001709 ,ZV-001554 ,ZV-001735 ,ZV-001463 ,ZV-001638 ,ZV-001580 ,ZV-001695 ,ZV-001726 ,ZV-001443 ,ZV-001474 ,ZV-001486 ,ZV-001508 ,ZV-001598 ,ZV-001606 ,ZV-001608 ,ZV-001692 ,ZV-001696 ,ZV-001782 ,ZV-001619 ,ZV-001664 ,ZV-001424 ,ZV-001433 ,ZV-001451 ,ZV-001457 ,ZV-001493 ,ZV-001512 ,ZV-001516 ,ZV-001543 ,ZV-001564 ,ZV-001581 ,ZV-001590 ,ZV-001602 ,ZV-001613 ,ZV-001641 ,ZV-001667 ,ZV-001671 ,ZV-001668 ,ZV-001680 ,ZV-001679 ,ZV-001684 ,ZV-001751 ,ZV-001593 ,ZV-001756 ,ZV-001535 ,ZV-001470  ,ZV-001539 ,ZV-001565 ,ZV-001624 ,ZV-001662 ,ZV-001752 ,ZV-001753 ,ZV-001647 ,ZV-001670 ,ZV-001704 ,ZV-001747 ,ZV-001660 ,ZV-001681 ,ZV-001783 ,ZV-001431 ,ZV-001434 ,ZV-001447 ,ZV-001482 ,ZV-001524 ,ZV-001550 ,ZV-001553 ,ZV-001586 ,ZV-001677 ,ZV-001734 ,ZV-001750 ,ZV-001770 ,ZV-001774 ,ZV-001784 ,ZV-001632 ,ZV-001459 ,ZV-001533 ,ZV-001518 ,ZV-001541 ,ZV-001538 ,ZV-001620 ,ZV-001467 ,ZV-001454 ,ZV-001546 ,ZV-001566 ,ZV-001477 ,ZV-001705 ,ZV-001505 ,ZV-001718 ,ZV-001719 ,ZV-001504 ,ZV-001609 ,ZV-001762 ,ZV-001724 ,ZV-001573 ,ZV-001600 ,ZV-001665  ,ZV-001694 ,ZV-001745 ,ZV-001517 ,ZV-001636 ,ZV-001582 ,ZV-001597 ,ZV-001612 ,ZV-001623 ,ZV-001439 ,ZV-001710 ,ZV-001754 ,ZV-001771 ,ZV-001510 ,ZV-001513 ,ZV-001523 ,ZV-001540 ,ZV-001599 ,ZV-001601 ,ZV-001640 ,ZV-001661 ,ZV-001699 ,ZV-001727 ,ZV-001766 ,ZV-001441 ,ZV-001764 ,ZV-001506 ,ZV-001744 ,ZV-001715 ,ZV-001757 ,ZV-001571 ,ZV-001674 ,ZV-001655 ,ZV-001414 ,ZV-001633 ,ZV-001732 ,ZV-001458 ,ZV-001509 ,ZV-001693 ,ZV-001547 ,ZV-001551 ,ZV-001639 ,ZV-001686 ,ZV-001725 ,ZV-001466 ,ZV-001649 ,ZV-001700 ,ZV-001438 ,ZV-001588 ,ZV-001730 ,ZV-001529  ,ZV-001530 ,ZV-001591 ,ZV-001626 ,ZV-001469 ,ZV-001468 ,ZV-001576 ,ZV-001579 ,ZV-001587 ,ZV-001596 ,ZV-001630 ,ZV-001689 ,ZV-001707 ,ZV-001713 ,ZV-001723 ,ZV-001736 ,ZV-001738 ,ZV-001410 ,ZV-001690 ,ZV-001484 ,ZV-001616 ,ZV-001729 ,ZV-001765 ,ZV-001556 ,ZV-001452 ,ZV-001478 ,ZV-001637 ,ZV-001657 ,ZV-001642 ,ZV-001651 ,ZV-001525 ,ZV-001522 ,ZV-001548 ,ZV-001698 ,ZV-001584 ,ZV-001739 ,ZV-001741 ,ZV-001622 ,ZV-001697 ,ZV-001743 ,ZV-001760 ,ZV-001678 ,ZV-001527 ,ZV-001528 ,ZV-001721 ,ZV-001788 ,ZV-001605 ,ZV-001572 ,ZV-001446 ,ZV-001549 ,ZV-001748  ,ZV-001409 ,ZV-001703 ,ZV-001644 ,ZV-001708 ,ZV-001444 ,ZV-001473 ,ZV-001645 ,ZV-001442 ,ZV-001552 ,ZV-001648 ,ZV-001787 ,ZV-001437 ,ZV-001643 ,ZV-001688 ,ZV-001706 ZV-001611.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Hong Kong, and China.
  • Product Description
    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. || Used by a person to move from one place to another while sitting.
  • Manufacturer
    Sunrise Medical (US) LLC

Manufacturer

Sunrise Medical (US) LLC
  • Manufacturer Address
    Sunrise Medical (US) LLC, 2842 N Business Park Ave, Fresno CA 93727-1328
  • Manufacturer Parent Company (2017)
    Sunrise Medical (Us) Llc
  • Source
    USFDA