International Medical Devices Database

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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