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  • Dispositivo 1229
  • Fabricante 1229
  • Evento 1230
  • Implante 0
220-240V Unit Cable (power cord) for Infusomat fmS, Infusomat P and SpaceCover
  • Modelo / Serial
    Affected power cords have been manufactured by B Braun supplier HAWA in the period from July 2016 (marked as M7 Y6) until June 2018 (marked as M6 Y8). The affected power cord has been shipped together with one of the following products: Infusomat P Deutsch 230 V (8712174), Infusomat P Netherlands 230 V (8712190), Infusomat P Czech 230 V (8712344), Infusomat P English 230 V (8712379), SpaceCover Comfort (8713145), SpaceCover Standard (8713147), Infusomat fmS Deutsch 230 V (8715424), Infusomat fmS Danish 230 V (8715432), Infusomat fmS Spanish 230 V (8715459), Infusomat fmS French 230 V (8715521), Infusomat fmS English 230 V (8715548), Infusomat fmS Italian 230 V (8715564), Infusomat fmS Czech 230 V (8715580) and as separate 220-240V Unit Cable (34502718).
  • Descripción del producto
    Infusion pumps, power cord
  • Manufacturer
    B Braun Medical Inc.
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
3.0T 6-Channel Flex Coils Used with Discovery MR750 3.0T Scanners Running DV24, DV25, or DV25.1 A...
  • Modelo / Serial
    Discovery 3.0T MR750 systems running Application software versions DV24 R01, DV25 R02, or DV25.1 M3, when used with the 3.0T 6 Channel Flex Coil.
  • Descripción del producto
    Scanning Systems, Magnetic Resonance Imaging, Extremity
  • Manufacturer
    GE Healthcare
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
3.0T GEMflex Coil
  • Modelo / Serial
    3.0T GEM Flex Coil 16-L Array 5430008-2 3.0T GEM Flex Coil 16-M Array 5430008-3 3.0T GEM Flex Coil 16-S Array 5430008-4 3.0T GEM Flex Interface 5430008-5
  • Descripción del producto
    Imaging device
  • Manufacturer
    GE Healthcare
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
3f Enable Aortic Bioprosthesis
  • Modelo / Serial
    3f Enable Aortic Bioprosthesis Model 6000
  • Descripción del producto
    Implants, non active
  • Manufacturer
    Medtronic Inc
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
3M™ Bair Hugger™ Full Access Underbody Warming Blanket
  • Modelo / Serial
    1) 3MTM Bair Hugger™ Full Access Underbody Warming Blanket 63500 Lot Nos.: R10359, R10360, R10361, R10362, R10363, R10364, R10365, R10366 2) 3MTM Bair Hugger™ Full Access Underbody Warming Blanket 63700 Lot Nos.: FR10361
  • Descripción del producto
    Warming Units, Patient, Forced-Air
  • Manufacturer
    3M Health Care Ltd
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
3M Ranger High Flow Disposable Set
  • Modelo / Serial
    Model 24355 Lot Numbers: HX 7223 and HX 7270
  • Descripción del producto
    fluid warming system
  • Manufacturer
    3M Health Care Ltd
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
3M Steri-Vac™ Gas Sterilizer/Aerator
  • Modelo / Serial
    Models 5XL and 8XL.
  • Descripción del producto
    Gas Sterilizer/Aerator
  • Manufacturer
    3M Health Care Ltd
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
3-Way Large Bore Stopcocks
  • Modelo / Serial
    All lots of product codes 2C6201, 2C6202, 1C8471, 2N5600, 3C0114, 3C0180, 3C0021, 3C0174, 3C0098, 3C0090 and 3C0175
  • Descripción del producto
    Stopcocks
  • Manufacturer
    Baxter Healthcare
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
4500MD Mass Spectrometer
  • Modelo / Serial
    QTRAP 4500MD (5031225) and Triple Quad 4500MD (5031225) - See attached file for details -
  • Descripción del producto
    in vitro diagnostic
  • Manufacturer
    AB SCIEX Pte. Ltd
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
4D Integrated Treatment Console
  • Modelo / Serial
    4D ITC versions 8.1 SP2 to 10.0 SP1. See attachment for Serial numbers
  • Descripción del producto
    Radiology information system (4DITC).
  • Manufacturer
    Varian Medical Systems
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
5 mm Versaport Bladeless Optical Trocars with Fixation Cannulae
  • Modelo / Serial
    Product numbers :- ONBFCA5ST, ONBFCA5SH, ONB5STF2C, ONB5STF, ONB5LGF, ONB5SHF, USUONB5LGF, USUONB5SHF, USUONB5STF, USUONBFCA5ST, Lot numbers NOT affected: N2H0045X, N2H0166X, N2H0286X, N2H0357X, N2H0516UX. Please see the attachment
  • Descripción del producto
    Trocars, Abdominal , Thoracic , Cannulae
  • Manufacturer
    Covidien LLC
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
8-Channel Lead for the St. Jude Medical Infinity™ DBS (Deep Brain Stimulation) System
  • Modelo / Serial
    Model No.: 6172ANS, 6170ANS Multiple batch & serial numbers (See attached FSN) UDI: 05415067020635, 05415067030306, 05415067020680, 05415067030320
  • Descripción del producto
    Implantable Pulse Generators
  • Manufacturer
    St. Jude Medical Inc.
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
ABACUS Total Parenteral Nutrition (TPN) Calculation Software
  • Modelo / Serial
    ABACUS Total Parenteral Nutrition (TPN) Calculation software Versions 2.0, 2.1, 3.0 and 3.1 (ABACUS). Product code: 8300-0046, 8300-0047
  • Descripción del producto
    Information Systems, Data Management, Provider Order Entry
  • Manufacturer
    Baxter Healthcare
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Absorbable and Non-Absorbable Sutures, Catgut, Vilene, Radene, Dyflex, Polyflex, Telflex, Dyloc, ...
  • Modelo / Serial
    Catgut, Vilene, Radene, Dyflex, Polyflex, Telflex, Dyloc, Nylene, Dysilk
  • Descripción del producto
    Absorbable and Non-Absorbable Sutures
  • Manufacturer
    Dynek Ltd
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Accelerator a3600
  • Modelo / Serial
    List number : 06P33 Serial Numbers : All
  • Descripción del producto
    Accelerator
  • Manufacturer
    Abbott
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Accelerator APS
  • Modelo / Serial
    List Number: 07L01 Serial Numbers : All
  • Descripción del producto
    Accelerator
  • Manufacturer
    Abbott
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
ACCELERATOR Automated Processing System (APS)
  • Modelo / Serial
    List Number : 07L02 ……………………………….. NCMDR update code : ACCELERATOR a3600 Centrifuge Module List Number : 06P37
  • Descripción del producto
    Centrifuge Module
  • Manufacturer
    Abbott
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Accelerator System, Linear, Clinac, Trilogy,
  • Modelo / Serial
    SERIAL NUMBERS: H140863 H294608 H294669 H294732 H140865 H294610 H294670 H294733 H140866 H294611 H294671 H294734 H140867 H294612 H294672 H294735 H140868 H294613 H294673 H294736 H140869 H294614 H294674 H294737 H140870 H294615 H294675 H294738 H140871 H294616 H294676 H294739 H140872 H294617 H294677 H294740 H140873 H294618 H294678 H294741 H140874 H294619 H294679 H294742 H140875 H294620 H294680 H294743 H140876 H294621 H294681 H294744 H140877 H294622 H294682 H294745 H140878 H294623 H294683 H294746 H140879 H294624 H294684 H294747 H140880 H294625 H294685 H294748 H140881 H294626 H294686 H294749 H140882 H294627 H294687 H294750 H140883 H294628 H294688 H294751 H140884 H294629 H294689 H294752 H140885 H294630 H294690 H294753 H140886 H294631 H294691 H294754 H140887 H294632 H294692 H294755 H140888 H294633 H294693 H294756 H140889 H294634 H294694 H294757 H140890 H294635 H294695 H294758 H140891 H294636 H294696 H294759 H140892 H294637 H294697 H294760 H140893 H294638 H294698 H294761 H140895 H294639 H294699 H294762 H140896 H294640 H294700 H294763 H140897 H294641 H294701 H294764 H140898 H294642 H294702 H294765 H140899 H294643 H294704 H294766 H140900 H294644 H294705 H294767 H181175 H294645 H294706 H294768 H181176 H294646 H294707 H294769 H181177 H294647 H294708 H294770 H181178 H294648 H294709 H294771 H181179 H294649 H294710 H294772 H181180 H294650 H294711 H181181 H294651 H294712 H181182 H294652 H294713 H181183 H294653 H294714 H181184 H294654 H294715 H181185 H294655 H294716 H181186 H294656 H294717 H181187 H294657 H294718 H181188 H294658 H294719 H181189 H294659 H294720 H181190 H294660 H294722 H181191 H294661 H294723 H181192 H294662 H294724 H182000 H294663 H294726 H182001 H294664 H294727 H182002 H294665 H294728 H182003 H294666 H294729 H182005 H294667 H294730 H294607 H294668 H294731
  • Descripción del producto
    Accelerator System, Linear
  • Manufacturer
    Varian Medical Systems
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Accelerator System, Linear, True Beam
  • Modelo / Serial
    True Beam 1.0
  • Descripción del producto
    Accelerator System, Linear,
  • Manufacturer
    Varian Medical Systems
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Accelerator System, TrueBeam
  • Modelo / Serial
    1.0, 1.5.12.0 and below, 1.6.9.5 and below Serial number attached
  • Descripción del producto
    Accelerator System, linear, prone patients
  • Manufacturer
    Varian Medical Systems
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Accent/ Anthem, Accent MRI/ Accent ST, Assurity/ Allure and Assurity MRI devices
  • Modelo / Serial
    Accent/ Anthem, Accent MRI/ Accent ST, Assurity/ Allure and Assurity MRI devices …………………………. FDA update codes: - Please Check attached file for update codes -
  • Descripción del producto
    Pacemaker
  • Manufacturer
    St. Jude Medical Inc.
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Access 2 Family of Immunoassay Systems
  • Modelo / Serial
    Access 2, Access 2, Remanufactured and the UniCel DxC 600i SYNCHRON Access Clinical Systems Ref: 81600N, 386220, A25637, A25638 For the affected Serial Numbers, please see the attached file.
  • Descripción del producto
    Analyzer, chemistry (photometric, discrete), for clinical use
  • Manufacturer
    Beckman Coulter
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Access BR Monitor used with the Access Family of Immunoassay Systems
  • Modelo / Serial
    REF No.: 387620 LOT : All Non-Expired Lots and Future Lots
  • Descripción del producto
    IVD Test Reagent/Kits, Molecular Assay, Gene Anomaly
  • Manufacturer
    Beckman Coulter
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Accu-Chek FlexLink Plus, Infusion administration set
  • Modelo / Serial
    GWX 001 up to GWX 206 GWY 001 up to GWY 034
  • Descripción del producto
    Infusion administration set, insulin
  • Manufacturer
    Roche Diagnostics Corp
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
Accurus Standalone Probe
  • Modelo / Serial
    Models are tabulated in the attachment
  • Descripción del producto
    Probes
  • Manufacturer
    Alcon Laboratories Inc.
  • 1 Event
    • translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
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