Devices

Device Recall Epic

  • Model / Serial
    Serial numbers 0512068638, 0512068639, 0512068640, 0512068641, 0512068642, 0512068667, 0512068668, 0512068669, 0512068670, 0512068725, 0512068726, 0512068727, 0512068728, 0512068740, 0512068750, 0512068751, 0409060679, 0409060680, 0409060681, 0409060682, 0409060683, 0409060684, 0409060685, 0409060686, 0409060687, 0512068643, 0512068644, 0512068645, 0512068646, 0512068647, 0512068648, 0512068649, 0512068650, 0512068651, 0512068652, 0512068653, 0512068654, 0512068655, 0512068656, 0512068657, 0512068658, 0512068659, 0512068660, 0512068661, 0512068662, 0512068779, 0512068780, 0512068781, 0512068782, 0512068783, 0512068784, 0512068785, 0512068709, 0512068710, 0512068711, 0512068712, 0512068713, 0512068714, 0512068715, 0512068716, 0512068717, 0512068718, 0512068719, 0512068720, 0512068721, 0512068722, 0512068723 and 0512068724.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World Wide--(Chile, Mexico and Singapore)
  • Product Description
    Stryker Epic Critical Care Bed; Model 2030.
  • Manufacturer
    Stryker Medical
  • 1 Event

Manufacturer

Stryker Medical
  • Manufacturer Address
    Stryker Medical, 6300 Sprinkle Rd, Kalamazoo MI 49001
  • Source
    USFDA

25 devices with a similar name

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Device Recall Epic 5100) Refractor and RT 3100 Refractor
  • Model / Serial
    serial numbers: See attached distribution list. 128 RT -3100 and 2565 RT-5100.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: || Product Usage: || Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.
  • Manufacturer
    Nidek Inc
Device Recall EpiCenter Plus Microbiology Data Management System
  • Model / Serial
    Lot Numbers Version 6.20A  Cat. Number 442953
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    15 US customers, 18 Ex-US sites, and 0 distributors. Approximately 115 customers totally and 0 distributors
  • Product Description
    EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . || Product Usage: || The EpiCenter system is a clinical data management system designed for use with certain BD instrument systems. The EpiCenter system provides advanced capabilities in data management, including extended demographic data, comprehensive reporting features including a powerful database query tool, bi-directional Laboratory Information System (LIS) communications and long-term data storage. Additionally, the EpiCenter system provides an Expert System that can manipulate and/or act upon AST results.
  • Manufacturer
    Becton Dickinson & Co.
Device Recall Epic Extremity Plate System
  • Model / Serial
    Catalog Number: 2111-0005 Lot: 51464
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The products were distributed to the following US states: FL, PA, and VA.
  • Product Description
    Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
  • Manufacturer
    Epic Extremity, LLC
Device Recall Epic Extremity Plate System
  • Model / Serial
    Catalog Number: 2111-1010 Lot: 51461
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The products were distributed to the following US states: FL, PA, and VA.
  • Product Description
    Epic Extremity Plate System,10x10 Plate Caddy, Part 2111-1010 with 2.7 and 3.5mm Non-Locking Screw (2001-27XX-N & 2001-35XX-N)
  • Manufacturer
    Epic Extremity, LLC
Device Recall Epic
  • Model / Serial
    Serial numbers 0512068663, 0512068664, 0512068665, 0512068666, 0512068681, 0512068682, 0512068741, 0512068742, 0512068743, 0512068744, 0512068745, 0512068746, 0512068747, 0512068748, 0512068749, 0512068762, 0512068763, 0512068759, 0512068760, 0512068764, 0512068765, 0512068766, 0512068767, 0512068768, 0512068769, 0512068770, 0512068771, 0512068772, 0512068773, 0512068774, 0512068775, 0512068776, 0512068777, 0512068778, 0601085035, 0601085036, 0601085064, 0601085141, 0601085142, 0601085143, 0512068671, 0512068672, 0512068673, 0512068674, 0512068675, 0512068676, 0512068677, 0512068678, 0512068679 and 0512068680.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World Wide--(Chile, Mexico and Singapore)
  • Product Description
    Stryker Epic Zoom Critical Care Bed; Model 2040.
  • Manufacturer
    Stryker Medical
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