Events

Recall of Device Recall Ascom Mobile Monitoring Gateway

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ascom US, 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
    73578
  • Event Risk Class
    Class 2
  • Event Number
    Z-1638-2016
  • Event Initiated Date
    2015-12-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144525
  • 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,network and communication,physiological monitors - Product Code MSX
  • Reason
    Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a software upgrade to one of the other affected versions. messages from ge carescape/nurse call will not forward to handset until primary module is restored.
  • Action
    On January 4, 2016 , the firm is initiating a field corrective action to update the software in the installed base and resynchronize the primary and secondary servers. All customers were sent a letter January 4, 2016, informing them of the voluntary recall of Ascom Mobile Monitoring Gateway and Unite Connect for Nurse Call. The reason stated for why the recall was initiated was that the secondary module would not take over the messaging function when the primary module failed, following a software upgrade. Ascom instructed customers to check if their software was one of the affected versions they should contact their local Ascom representative to review the MMG configuration and determine if the system is subject to malfunction. The same instructions were directed towards those who were not able to determine their software version. If it is determined that the program is subject to malfunction, the primary and secondary modules should be re-synchronized. A test of module redundancy should be conducted on re-synchronized modules. The second module should take over for the primary module within thirty seconds. Model redundancy should be tested frequently and following system upgrades. For more information call (919) 535-6143 , 8am till 4:30pm.

Device

Device Recall Ascom Mobile Monitoring Gateway
  • Model / Serial
    Ascom Mobile Monitoring Gateway version 4.1.1 & 4.2.0 and Ascom Unite Connect for Nurse Call version 2.2.0
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, NJ, NM, OH, OK, PA, TN, TX, VA, WA, WI and Hawaii. Australia, Austria, Belgium, Canada, France, Germany, Netherlands, Poland, Qatar, Sweden, Switzerland, and United Arab Emirates.
  • Product Description
    Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0).
  • Manufacturer
    Ascom US, INC.

Manufacturer

Ascom US, INC.
  • Manufacturer Address
    Ascom US, INC., 300 Perimeter Park Dr Ste D, Morrisville NC 27560-9703
  • Source
    USFDA