Events

Recall of Device Recall GE QUASAR NUCLEAR MEDICINE SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems, 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
    50918
  • Event Risk Class
    Class 2
  • Event Number
    Z-1002-2009
  • Event Initiated Date
    2008-06-02
  • Event Date Posted
    2009-04-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78025
  • 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 healthcare has recently became aware of excessive pressure applied by the collimator pressure sensitive cover of infinia (infinia, infinia hawkeye¿, infinia hawkeye¿ 4) that may impact patient safety. it was reported at a customer site that the pressure used to activate the pressure sensitive device (psd) should be lowered and that the body contouring software requires correction to prevent po.
  • Action
    Consignees were sent from June 2008 to February 2009 a GE "Product Safety Notification" letter dated April 2008. The letter was addressed to Hospital Administrators and Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information. A GE Healthcare service representative will contact each consignee to schedule the installation of the Pressure Sensitive Device (PSD). Please contact your local sales or service representative for further information regarding this recall. Further information can be found by calling 1-800-437-1171 in the US or Canada or 1-262-896-2890 if outside the US.

Device

Device Recall GE QUASAR NUCLEAR MEDICINE SYSTEM
  • Model / Serial
    Model Number: H3000WR, Lot Numbers:  16306 and 16275;  Model Number: H3000WW, Lot Numbers: 16086 16202 16231 16241 16268 16265 16247 16277 16201 16272 16274 16258 16278 16242 16257 16341 16307 16232 16351 16358 16363 16383 16134 16383 16367 16095 16359 16338 16390 16407 16253 16463 16242 16461 16484 16467 16472 16486 16393 16488 16507 16545 16459 16546 16523 16550 16521 16402 16417 16599 16556 16480 16558 16597 16555 16590 16603 16598 16606 16618 16630 16596 16530 16619 16609 16631 16623 16691 16708 16620 16633 16642 16599 16703 16591 16671 16764 16757 16604 16787 16615 16287 16690 16568 16458 16711 16727 16386 16729 16444 16260 16678 16687 16588 16700 16653 16730 16782 16824 16342 16879 16003 16801 16884 16292 16906 16892 16931 16952 16954 16222 16936 16895 16257 16951 16373 16958 16389 16982 16981 17038 16754 16985 16998 16855 16458 16644 and 16544,  Model Number: H3000WZ, Lot Numbers: 16237 16350 16251 16375 16387 16512 16565 16582 16403 16240 16183 16572 16485 16552 16248 16215 16261 16197 16468 16361 16624 16813 16409 16831 16481 16240 16264 16891 16961 16826 and 17148,  Model Number: H3000YM, Lot Numbers: 16046 16011 16021 16057 16027 16128 16077 16097 16019 16103 16082 16112 16029 16121 16157 16148 16159 16038 16147 16146 16127 16154 16174 16024 and 16133 and  Model Number: H3000YS, Lot Numbers: 16068 16089 16141 16085 and 16061.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution US (and Puerto Rico) including states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV and WI and countries of Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hungry, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Republic of Georgia, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine and the United Kingdom.
  • Product Description
    GE Healthcare Infinia Hawkeye¿, Model Numbers: H3000WR, H3000WW, H3000WZ, H3000YM and H3000YS. || Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

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