Devices

Device Recall ERGO

  • Model / Serial
    ERGO++ Release 1.6.3 and 1.6.3.1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to medical facilities in CA, MO, NC, ND, NV, NY, OH, OK, TX, and WA. Foreign distribution was made to Brazil, Cuba, Czech Republic, France, Germany, India, Italy, Japan, Malaysia, Poland, Portugal, Serbia, and Spain.
  • Product Description
    ERGO++ Stereotactic Radiation Treatment Planning System, ERGO++ Release 1.6.3 and 1.6.3.1 || Product Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy has been prescribed. It is an accessory to linear accelerators used for radiation therapy. It is indicated for use in the planning of 3-dimensional radiation therapy.
  • Manufacturer
    Computerized Medical Systems Inc
  • 1 Event

Manufacturer

Computerized Medical Systems Inc
  • Manufacturer Address
    Computerized Medical Systems Inc, 13723 Riverport Drive, Suite 100, Maryland Heights MO 63043
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

Device Recall Ergon III Series Skyboom Monitor Bracket
  • Model / Serial
    Model Number(s): 3FCM1; Manufactured Date: September 2015; Serial Numbers 1507T719-00-0-0074, 1507T719-00-0-0091, 1507T719-00-0-0095, 1507T719-00-0-0096, 1507T719-00-0-0102, 1507T719-00-0-0107, 1508T719-00-0-0129, 1507T719-00-0-0087, 1507T719-00-0-0069, 1507T719-00-0-0103, 1507T719-00-0-0104, 1507T719-00-0-0066, 1507T719-00-0-0072, 1507T719-00-0-0073, 1507T719-00-0-0075, 1507T719-00-0-0088, 1507T719-00-0-0101, 1507T719-00-0-0108, 1507T719-00-0-0112, 1507T719-00-0-0113, 1507T719-00-0-0090, 1507T719-00-0-0097, 1507T719-00-0-0099, and 1507T719-00-0-0100
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US states: VA, VT, UT, GA, NJ, and IL; Japan.
  • Product Description
    Ergon III Series Skyboom Monitor Bracket. Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
  • Manufacturer
    Skytron, Div. The KMW Group, Inc
Device Recall Ergolift and Ergolift2 Floor LIfts
  • Model / Serial
    serial numbers ERLI-0001 through ERLI-1717, manufactured between 1995 and 1999
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Ergolift 400 Lbs. Floor Lift, Manufactured by BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada, J1X 5Y5; model/part numbers ERGOLIFT and ERGOLIFT-2 || The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients.
  • Manufacturer
    Arjo, Inc.