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U.S. Department of Health and Human Services

Class 2 Device Recall Sunrise Brand Zippie Voyage

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  Class 2 Device Recall Sunrise Brand Zippie Voyage see related information
Date Initiated by Firm November 11, 2013
Date Posting Updated December 05, 2013
Recall Status1 Terminated 3 on March 18, 2014
Recall Number Z-0453-2014
Recall Event ID 66896
510(K)Number K123975  
Product Classification Wheelchair, mechanical - Product Code IOR
Product 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.
Code Information 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..
Recalling Firm/
Manufacturer
Sunrise Medical (US) LLC
2842 N Business Park Ave
Fresno CA 93727-1328
For Additional Information Contact Laurie H. Roberts
559-294-2395
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Nonconforming Material/Component
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.
Quantity in Commerce 316 units in US, 29 units international
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, Hong Kong, and China.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IOR and Original Applicant = SUNRISE MEDICAL
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