Events

Recall of Device Recall RapidScreen RS2000D.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Riverain Medical Group.

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
    35456
  • Event Risk Class
    Class 3
  • Event Number
    Z-1173-06
  • Event Initiated Date
    2006-05-04
  • Event Date Posted
    2006-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46158
  • 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
    Medical Image Analyzer - Product Code MYN
  • Reason
    The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). the product is approved to have a sensitivity of 63.3% and a specificity of 5.0. thus, there is a difference of -5.1% in sensitivity and +1.1 in specificity.
  • Action
    The recalling firm sent a letter dated 5/4/06 to medical facilities, sent a letter dated 5/5/06 to distributors, and sent a letter dated 5/10/06 to GE Healthcare, Waukesha, WI.

Device

Device Recall RapidScreen RS2000D.
  • Model / Serial
    Serial numbers: 39CKM51, 1BCKM51, 25-1034, 4BCKM51, F9CDM51, 25-1011, 25-1012, 25-1013, 25-1015, 25-1017, 25-1021, 25-1025, 25-1028, 25-1029, 25-1023, 25-1024, 25-1027, 25-1033, 25-1030, 25-1031, 25-1035, 25-1036, 25-1032, 25-1037, 25-1038, 25-1039, 25-1041, 25-1042.
  • Product Classification
    Radiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide. The product was distributed to consignees located in IL, CA, MO, CO, WA, MT, ID, OR, NC, TX, TN, FL, UT, MN, OK, WI, OH, AZ, IA, and PA.
  • Product Description
    RapidScreen RS-2000D, Medical Image Analyzer.
  • Manufacturer
    Riverain Medical Group

Manufacturer

Riverain Medical Group
  • Manufacturer Address
    Riverain Medical Group, 3020 S Tech Blvd, Miamisburg OH 45342-4860
  • Source
    USFDA