Events

Recall of Device Recall Ambra PACS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DICOM GRID 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
    76187
  • Event Risk Class
    Class 2
  • Event Number
    Z-1045-2017
  • Event Initiated Date
    2016-12-16
  • Event Date Posted
    2017-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152488
  • 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
    A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance.
  • Action
    On 12/16/16 a fix is the software issue was conducted via remote cloud system. On 01/11/17 customers were sent Release Notes that addressed the software correction. The issue was resolved and required no further action.

Device

Device Recall Ambra PACS
  • Model / Serial
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. distribution to the following; TX, FL, NE, CA, WI, AZ, NH, MO, MA, CO, PA, NV, PR, IL, OH, NY, MD, NJ, MN, MI, CT, VA, GA, UT, KS, WA, MI, HI. Foreign distribution to the following; Canada, Spain, Israel, Singapore, Kosovo, Austria, Brazil, Malaysia, Australia.
  • Product Description
    Ambra PACS || UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R || Software Version Number: V3.16.13.0 || Intended for use as a primary diagnostic and analysis tool for diagnostic images.
  • Manufacturer
    DICOM GRID INC

Manufacturer

DICOM GRID INC
  • Manufacturer Address
    DICOM GRID INC, 4530 E Muirwood Dr, Ste. 113, Phoenix AZ 85048-7639
  • Manufacturer Parent Company (2017)
    Ambra Health Inc.
  • Source
    USFDA