BEUDAMED
    34 results · 13ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Open, Classified × Clear all

    Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia

    FDA Recall
    Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·December 16, 2024

    Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia

    FDA Recall
    Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·December 16, 2024

    Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia

    FDA Recall
    Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·December 16, 2024

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

    FDA Recall
    Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·December 4, 2024

    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.

    FDA Recall
    Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·December 4, 2024

    Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier

    FDA Recall
    Open, Classified ·Breas Medical, Inc.·Product code NOU·June 2, 2022

    Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular. (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr. Ross Minor Vascular, Sterile; (4) Presource PBDS, Cat. PV30VPUHA, Univ Hlth Net Toronto Gen Hosp, Kit, Tavi, Sterile; (5) Presource Cat Pack, Cat. SANOCCPDM2, DMAC Vascular Lab LLC, Sterile; (6) Presource Pacemaker Pack, Cat. SAN1FPMULM, U of L Health, Sterile; (7) Presource OR Angio Pack, Cat. SAN11OADMM, Suny Downstate, Sterile; (8) Presource Device Implant Pack, Cat. SAN13DILCO, BILH Lahey Hospital Burlington, Sterile; (9)Presource Device Implant Pack, Cat. SAN13DILC6, BILH Lahey Hospital Burlington, Sterile; (10) Presource AOG Pack, Cat. SAN21AO62F, CHI Memorial Hospital Chattano, Sterile; (11) Presource Angio Pack, Cat. SAN21APJCD, Ballad Health, Sterile; (12) Presource Implant Pack, Cat. SAN21IP62I, CHI Memorial Hospital Chattano, Sterile; (13) Presource Pacemaker Pack, Cat. SAN23CMCW5, Catawba Valley Medical Center, Sterile; (14) Presource Pacemaker Pk, Cat. SAN29PCCCL, Cleveland Clinic Health System, Sterile; (15) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDKOC, KP Oakland Med Center, Sterile; (16) Presource Permanent Pacing Drape Pack, Cat. SAN3BPDK12, KP Oakland Med Center, Sterile; (17) Presource Femoral Angioplasty, Cat. SAN30ANTHD, Trillium Health Centre, Sterile; (18) Presource VGH Pacemaker Pack, Cat. SAN30PPVGA, Vancouver General Hospital, Sterile; (19) Presource Cat Lab Implant Pack, Cat. SAN32IPJWA, Jewish Hospital, Sterile; (20) Presource Thomas Health System Cath Pack, Cat. SAN33HCSFI, St. Francis Hospital, Sterile; (21) Presource Pacemaker Pack, Cat. SAN33PMDWI, Doctors Hospital, Sterile; (22) Presource OR Percutaneous Pack, Cat. SAN53OPVMG, Virginia Mason Medical Center, Sterile; (23) Presource Pacemaker Pack, Cat. SAN55PMMMK, KP Maui Memorial Medical Cente, Sterile; (24) Presource Pacemaker Pack, Cat. SAN55PMMM9, KP Maui Memorial Medical Cente, Sterile; (25) Presource Pacemaker Insertion Pack, Cat. SAN57PM80G, Salem Health, Sterile; (26) Presource Endovascular Pack, Cat. SAN69ENKBK, KP Baldwin Park Med Cntr, Sterile (27) Presource Vascular Procedure Pack, Cat. SCVOCVACMI, Starling Physicians Access Cen, Sterile; (28) Presource HFHS Vasc Access Endo Vasc Pk, Cat. SCVW1VAHFL, Henry Ford Health System, Sterile; (29) Presource AV Access Pack, Cat. SCV11AVDMF, Suny Downstate, Sterile; (30) Presource AV Access Pack, Cat. SCV11AVD13, Suny Downstate, Sterile; (31) Presource TAVR Bundle Pack, Cat. SCV11TBTJH, Part 1 of 2 and Part 2 of 2, Thomas Jefferson University, Sterile; (32) Presource EVAR, Cat. SCV30EVTHE, Trillium Health Centre, Sterile; (33) Presource RHS Pacemaker, Cat. SCV30PMRGA, Richmond Hospital, Sterile; (34) Presource Perc Pack, Cat. SOT30PCHSC, Health Science Centre, Sterile.

    FDA Recall
    Open, Classified ·Cardinal Health 200, LLC·Product code OEZ·August 16, 2023

    AcoSound. Model Number: LW12-BTE-M

    FDA Recall
    Open, Classified ·HANGZHOU ACOSOUND TECHNOLOGY CO., LTD. No.2 Building Room 401 No.·Product code QUG·April 25, 2025

    GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024

    GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024

    GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024

    GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024

    GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024

    GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024

    GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024

    GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; 4) 2373519; 5) 2379827; 6) 5729352; 7) 2259973-1; 8) 2259973-2; 9) 2259973-3; 10) 2259973-4; 11) Not Available

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code KPR·July 12, 2024

    GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580, or Discovery CT590 RT; X-ray/computed tomography system

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024

    GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code JAK·November 5, 2024

    SIGNA Creator, SIGNA Explorer, NMRI systems

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code LNH·January 31, 2025

    Optima MR360, NMRI system

    FDA Recall
    Open, Classified ·GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China·Product code LNH·January 31, 2025