Events

Recall of Device Recall Brivo NM615

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

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
    65579
  • Event Risk Class
    Class 1
  • Event Number
    Z-1790-2013
  • Event Initiated Date
    2013-06-13
  • Event Date Posted
    2013-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119852
  • 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, tomography, computed, emission - Product Code KPS
  • Reason
    Ge became aware of an incident at a va medical center facility in the us in which a patient died due to injuries sustained while being scanned on an infinia hawkeye 4 nuclear medicine system. update: on july 03, 2013 ge notified hospitals that they are recalling several nuclear medicine imaging systems because serious injuries or deaths could occur due to the failure mode associated with this re.
  • Action
    GE sent an Urgent Medical Device Correction letter dated June 17, 2013 to all affected customers. The letter identified the affected product, recommended that qualified service personnel maintain the equipment and that Preventative Maintenance procedures are executed according to labeling. Also the Safety Chapter Sections should be re-reviewed with personnel to ensure proper operation of the equipment. GE notified customers again on July 03, 2013, via Urgent Medical Device Recall letter (including confirmation of delivery for US customers) and follow-up telephone call. Customers were instructed to cease using the affected system until GE Healthcare Field Engineer can complete an inspection of the system and perform any necessary repairs at no cost. A GE Healthcare representative will contact the hospitals to arrange for the inspection.

Device

Device Recall Brivo NM615
  • Model / Serial
    System ID: 030151NU17, 387171NU01, 405456NM615, 406222LN615, 478272NM, 702304NM615, A5635609, HC0541NU03, HC3366NU02, NM24011, NM24015, ZA1819NM04, ZA2446NM01.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.
  • Product Description
    Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. || Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce cross-sectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types. This generic type of device may include signal analysis and display equipment, patient and equipment supports, and accessories.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA