BEUDAMED
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    B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code MHX·November 16, 2022

    B125M Patient Monitor, REF 6160000-005-XXXXXXX

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code MHX·November 16, 2022

    B105M Patient Monitor, REF 6160000-003

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code MHX·November 16, 2022

    B125M Patient Monitor, REF 6160000-004-XXXXXX

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code MHX·November 16, 2022

    B125P Patient Monitor (with E-module slot option), REF 6160000-002

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code MHX·November 16, 2022

    epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·December 12, 2022

    Spacelabls Medical, Ultraview Multigas Analyzer, Model 91518,Spacelabs Healthcare, Issaquah, WA, 98027

    FDA Recall
    Terminated ·Spacelabs Healthcare, Incorporated·Product code CBR·October 8, 2007

    ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal suture knots during minimally invasive cardiac surgery.

    FDA Recall
    Terminated ·Edwards Lifesciences, LLC·Product code DPT·August 26, 2015

    MICRO-X Rover Mobile X-ray System, # MXU-RV35

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·October 22, 2024

    epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, Refurbished 10736433 epoc Host 2, US (MC55X) 11413524 epoc Host 2, ROW (MC55X) 11413528 epoc Host 2, India (MC55X) 11413541 epoc Host 2, China (MC55X) 11413542 epoc Host 2, Japan (MC55X) 11413543 epoc Host 2 (MC55X) - US - Refurbished 11413601 "epoc Host 2 (MC55X) - ROW -Refurbished" 11413602 epoc Host 2 (MC55X) - India - Refurbished 11413603 epoc Host 2 (MC55X) - Japan - Refurbished 11413604

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·December 12, 2022

    Endeavor Resolute Zotarolimus-Eluting Coronary Stent System with Rapid Exchange Delivery System, UPN 00613994400505, model #IDERES25024X. Manufacturer: Medtronic, Inc. Minneapolis, MN. Manufactured in: Medtronic Ireland, Galway, Ireland. Product is packaged inside a sterile, inner pouch, labeled in part "Use immediately". Inner pouch is supposed to be within a foil pouch containing desiccant, and moisture absorber. Foil pouch label reads in part "RX Endeavor Resolute Zotarolimus-Eluting Coronary Stent System...2.5 mm X 24 mm...REF IDERES25024X...Contents: One (1) Endeavor Resolute zotarolimus-eluting stent mounted on a rapid exchange stent delivery system...Guide Catheter/Minimum Inner Diameter >=5F/0.056" (1.42 mm)...Maximum Guidewire Diameter 0.014" (0.36 mm)...Maximum Stent I.D. 3.00 mm (0.12"...Nominal Pressure 9 atm (912 kPa)...Rated Burst Pressure 15 atm (1520 kPa)...MR Conditional...Sterilized using ethylene oxide Consult instructions for use...Manufacturer: Medtronic, Inc. 710 Medtronic Pkwy NE Minneapolis, MN 55432 USA...Manufactured In: Medtronic Ireland Parkmore Business Park West, Galway, Ireland Tel:+353-91-708000 Fax:+353-91-757524 Investigational Devices / Returned Goods: Tel: (800) 556-4247 / Fax: (877) 518-2469...BioLinx Medtronic Polymer System". Foil pouch contents and Instructions for Use are placed within an outer box, which is labeled identically to the foil pouch. The Endeavor Resolute System is intended for use in patients with ischemic heart disease due to stenotic lesions contained within de novo native coronary arteries with reference vessel diameters between 2.25mm and 4.2mm and lesion lengths S 27mm that are amenable to percutaneous treatment with a stent.

    FDA Recall
    Terminated ·Medtronic Vascular Galway Limited Parkmore Business Park West Galway Ireland·Product code NIQ·August 6, 2009

    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654225.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005

    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925574325.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005

    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925754335.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005

    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925774325.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005

    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925554325.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005

    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654335.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005

    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925474325.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005

    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654325.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005

    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674335.

    FDA Recall
    Terminated ·Smiths Medical PM, Inc.·Product code DPS·March 16, 2005