Events

Recall of Device Recall Syngo Dynamics

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73479
  • Event Risk Class
    Class 2
  • Event Number
    Z-1183-2016
  • Event Initiated Date
    2016-01-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144270
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, image processing, radiological - Product Code LLZ
  • Reason
    Siemens' conducting a recall due to a potential issue when using the measurement package of the va10 version of syngo dynamics.
  • Action
    The firm, Siemens Healthcare, sent a "Customer Advisory Notice" dated 1/19/2016 to customers. The notice described the product, problem and actions to be taken. The customers were instructed to follow the instructions provided on what steps the user can take to avoid the issue and to forward the notice to the new owner, if you sold this device/equipment and its no longer in your possession. Siemens is preparing a modification of syngo Dynamics that will resolve this potential malfunction. If you have any question, contact Regulatory Technician Specialist at 610-448-6478 or email: Anastasia.sokolova@siemens.com.

Device

Device Recall Syngo Dynamics
  • 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
    Radiology Devices
  • 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
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA