Device Recall syngo Dynamics

  • Model / Serial
    Model Number: 10091637, 10091805, with serial numbers 85164, 85289, 85296, 85297, 85149, 85116, 85177, 85051, and 85278.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution only including the states of PA, OH, UT, CA, NY, MO, and TX.
  • Product Description
    syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. || The syngo¿ Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. || syngo¿ Dynamics is not intended to be used for reading mammography images.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    Serial #:  85170, 85175, 85346, 85362, 85082, 85083, 85450, 85479, 85035, 85476, 85358,8 4184, 85191, 85377,8 5387, 85903, 85487, 85060, 85415, 85857, 85858,85856,85339,85410,85381,85189,85860, 85447, 85448, 85895,85896, 85401,85368, 85307, 85308, 85309, 85310, 85396, 85399, 85400, 85872, 85873, 85874, 85875, 85876, 85899, 85341, 85421, 85422, 85485, 85332, 85409, 85870, 85850,85851,85360,85143, 85395, 85359,85879, 85108,85225, 85234, 85235, 85194,85195,85436, 85437,85334 85239, 85322, 85462, 85355, 85356, 85364, 85365, 85433, 85910,85881,85149, 85354, 85366, 85199, 85364,85040,85474, 85282,85054,85382,85049, 85085,85338,85865, 85147,85148, 85115, 85866, 85867,85073, 85440,85319,85342, 85343, 85438, 85426, 85062, 85067, 85353, 85918,85145,85441, 85330,85909,85407, 85079, 85080, 85456, 85050, 85908, 85176, 85172, 85335, 85484, 85424,85859, 85177,85045,85047,85897,85389, 85051, 85053, 85036, 85244,85248,85340, 85884,85886,85118, 85329, 85852,85418,85390, 85391,85361,85146, 85090, 85091, 85458,85092, 85099, 85880, 85883,85394,85403,85404, 85465, 85086, 85081,85414, 85416,85393, 85887, 85420, 85376, 85427, 85380, 85041,85042, 85891, 85186,85477, 85020, 85021,85325, 85350,85023,85024,85066, 85057, 85178,85900, 85871, 85435, 85345, 85352, 85481,85482, 85167,85168, 85470, 85453, 85442, 85321, 8585893,85468,85469, 85388,85157, 85232, 85187, 85439, 85848, 85223, 85016, 85017,85375, 85383,85384,85385, 85373, 85374, 85281, 85344, 85905,85904, 85906,85144,85326, 85327, 85473,85467, 85134, 85133, 85238, 85370, 85911, 85357
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including states of: MN, NC, NE, FL, TX, CA, AR, MI, MA, IL, DE, VA, SC, OH, CO, WI, MO, NY, CT, UT, PA, WA, NJ, GA, IN, MD, TN, LA, OR, AZ, ND, KS, AL, NM.
  • Product Description
    Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 || intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Not intended for reading of mammography images.
  • Manufacturer
  • Model / Serial
    All units. Version 5.0
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system.
  • Manufacturer
  • Model / Serial
    Serial numbers 10091602 and 10091604
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    syngo Dynamics Picture Archiving Communication System || The software is a picture archiving and communication system intended for acceptance, transfer, display, storage, archive, and manipulation of digital medical images including quantification and report generation.
  • Manufacturer
  • Model / Serial
    10091862 and 10091863
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- MA, GA, MO, IA, CA, PA, OR, CO, NY, NJ, WA, UT, OH, WI, MI, KY, and NC.
  • Product Description
    syngo Dynamics Version 9.5
  • Manufacturer
  • Model / Serial
    10091602, 10091604
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: CA, CT, FL, ID, MD, MI, MN, NJ, NY and PA.
  • Product Description
    syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI. || The syngo Dynamics is a picture archiving and communications system intended for acceptance, transfer, display, storage, archiving and manipulation of digital medical images, including quantification and report generation. It is not intended to be used for the reading of mammography images.
  • Manufacturer