Events

Recall of Device Recall Innova 2000

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
    52703
  • Event Risk Class
    Class 2
  • Event Number
    Z-2240-2009
  • Event Initiated Date
    2009-07-31
  • Event Date Posted
    2009-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83678
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Reason
    Ge healthcare has recently became aware of a potential power supply failure with the innova¿ 2000, 3100 and 4100 systems that may impact patient safety. a potential power supply failure inside the ge equipment cabinet could occur with no advance warning and thereby prevent x-ray generation and image processing. should this occur, the system cannot be restarted.
  • Action
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated June 25, 2009. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology or Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. GE Healthcare will correct all affected systems by replacing the power supply located in the GE equipment cabinet. A GE Healthcare service representative will contact you to arrange for this correction. Direct questions about the recall to the firm's Call Center by calling: 1-800-437 -1171, option 4 (United States) or 0120 - 055 - 919 (Japan). For other countries, please contact your local GE Healthcare field service Representative if you have any questions or concerns regarding the notification.

Device

Device Recall Innova 2000
  • Model / Serial
    00000424731BU8 00000416084BU2 00000423587BU5 00000415812BU7 00000418005BU5 00000393455BU1 00000397050BU6 00000419071BU6 00000423555BU2 00000422097BU6 00000423545BU3 00000409300BU1 00000389501BU8 00000398913BU4 00000395216BU5 00000423003BU3 00000415056BU1 00000420520BU9 00000418004BU8 00000419716BU6 00000400569BU0 00000423644BU4 00000423322BU7 00000405271BU8 00000392274BU7 00000400526BU0 00000404101BU8 00000399595BU8 00000392563BU3 00000424821BU7 00000422239BU4 00000403685BU1 00000403431BU0 00000397051BU4 00000403733BU9 00000409881BU0 00000382877BU9 00000420841BU9 00000415705BU3 00000407957BU0 00000387489BU8 00000418299BU4 00000393646BU5 00000393730BU7 00000397054BU8 00000424046BU1 00000399750BU9 00000404675BU1 00000405835BU0 00000409880BU2 00000419653BU1 00000407956BU2 00000397405BU2 00000402924BU5 00000394043BU4 00000419496BU5 00000413029BU0 00000419167BU2 00000408611BU2 00000397641BU2 00000400646BU6 00000420032BU5 00000417822BU4 00000418416BU4 00000424701BU1 00000422426BU7 00000395214BU0 00000397053BU0 00000392773BU8 00000420898BU9 00000388900BU3 00000407950BU5 00000397407BU8 00000389097BU7 00000389796BU4 00000389994BU5 00000397644BU6 00000397643BU8 00000394210BU9 00000390720BU1 00000418277BU0 00000424700BU3 00000421317BU9 00000389995BU2 00000424693BU0 00004093368BU8 00000399939BU8 00000392732BU4 00000399939BU8 00000424660BU9 00000416123BU8 00000397406BU0 00000391287BU0 00000416885BU2 00000420110BU9 00000411395BU7 00000411170BU4 00000401024BU5 00000413030BU8 00000394212BU5 00000421580BU2 00000426713BU4 00000423873BU9 00000411171BU2 00000404677BU7 00000407657BU6 00000406023BU2 00000406108BU1 00000395518BU4 00000400097BU2 00000437991BU3 00000425360BU5 00000412256BU0 00000417822BU4 00000426862BU9 00000436762BU9 00000437318BU9 00000432631BU0 00000423647BU7 00000415563BU6 00000404102BU6 00000402251BU3 00000392245BU7 00000426880BU1 00000409162BU5 00000392766BU2 00000440232BU7 00000440085BU9 00000391391BU0 00000393731BU5 00000421196BU7 00000400664BU9 00000401287BU8 00000418303BU4 00000423197BU3 00000395213BU2 00000424501BU5 00000388606BU6 00000418290BU3 00000407088BU4 00000426554BU2 00000425213BU6 00000394046BU7 00000416881BU1 00000424950BU4 00000402054BU1 00000422787BU2 00000415426BU6 00000418425BU5 00000427302BU5 00000402250BU5 00000426551BU8 00000419206BU8 00000427075BU7 00000417861BU2 00000417880BU2 00000412511BU8 00000419308BU2 00000407953BU9 00000410223BU2 00000398010BU9 00000420495BU4 00000410337BU0 00000397645BU3 00000419394BU2 00000418238BU2 00000388258BU6 00000393000BU5 00000422314BU5 00000410853BU6 00000417028BU8 00000421143BU9 00000405330BU2 00000415820BU0 00000390602BU1 00000404678BU5 00000421104BU1 00000416889BU4 00000397052BU2 00000399753BU3 00000408875BU3 00000424699BU7 00000410336BU2 00000393732BU3 00000423327BU6 00000403125BU8 00000387849BU3 00000437991BU3 00000398008BU3 00000415052BU0 00000392999BU9 00000392236BU6 00000400349BU7 00000416277BU2 00000415567BU7 00000395215BU7 00000403889BU9 00000424933BU0 00000419135BU9 00000404104BU2 00000415178BU3 00000399385BU4 00000403929BU3 00000407081BU9 00000403800BU6 00000425964BU4 00000404082BU0 00000404103BU4 00000410516BU9 00000395515BU0 00000423214BU6 00000408100BU6 00000409042BU9 00000409301BU9 00000426942BU9 00000424733BU4 00000390184BU0 00000397404BU5 00000398009BU1 00000395212BU4 00000421902BU8 00000389096BU9 00000421110BU8 00000418279BU6 00000401794BU3 00000445624BU0 00000410669BU6 00000403023BU5 00000446840BU1 00000417673BU1 00000416963BU7 00000399601BU4 00000391288BU8 00000392087BU3 00000424551BU0 00000400898BU3 00000420895BU5 00000400746BU4 00000403124BU1 00000419495BU7 00000411057BU3 00000395517BU6 00000419220BU9 00000418278BU8 00000392765BU4 00000425963BU6 00000422429BU1 00000418046BU9 00000410945BU0 00000382876BU1 00000409830BU7 00000425718BU4 00000446890BU6 00000413390BU6 00000415702BU0 00000426727BU4 00000418210BU1 00000395516BU8 00000416241BU8 00000402055BU8 00000393734BU9 00000421695BU8 00000411199BU3 00000423036BU3 00000416240BU0 00000399715BU2 00000393733BU1 00000425771BU3 00000420411BU1 00000405951BU5 00000387866BU7 00000425142BU7 00000417895BU0 00000404676BU9 00000422423BU4 00000425370BU4 00000416729BU2 00000418197BU0 00000416788BU8 00000422955BU5 00000416908BU2 00000426650BU8 00000409001BU5 00000422567BU8 00000422432BU5 00000417997BU4 00000417032BU0 00000410737BU1 00000406234BU5 00000367086BU6 00000392468BU5 00000407647BU7 00000419070BU8 00000417921BU4 00000421359BU1 00000417570BU9 UNK2252302-200 00000425360BU5 00000401211BU8 00000400097BU2 00000400151BU7 00000408597BU3 00000394213BU3 00000393185BU4 00000409163BU3 00000409827BU3 00000418415BU6 00000400186BU3 00000401600BU2 00000397642BU0 00000393647BU3 00000409155BU9 00000416563BU5 00000416671BU6 00000398011BU7 00000393186BU2 00000388459BU0 00000420104BU2 00000412931BU8 00000394045BU9 00000391181BU5 00000405374BU0 00000408840BU7 00000404430BU1 00000394211BU7 00000388087BU9 00000406580BU1 00000416632BU8 00000405768BU3 00000417594BU9 00000413030BU8 00000416580BU9 00000417599BU8 00000422771BU6 00000421701BU4 00000422469BU7 00000394209BU1 00000392580BU7 00000416864BU7 00000418000BU6 00000407955BU4 00000406792BU2 00000427204BU3 000000393456U9 00000406785BU6 00000394044BU2 00000408600BU5 00000421608BU1 00000411914BU5 00000423019BU9 00000398007BU5 00000389235BU3 00000397408BU6 00000387191BU0 and 00000403958BU2.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (states of AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA., MI, MN, MO, NE, NV, NH, NJ, NY, NC, OH, OK , OR, PA, PR, RI, SC, TN, TX, UT VA, WA, WI and WV), TUNISIA, THAILAND , TAIWAN, SYRIAN ARAB REPUBLIC, SWEDEN SPAIN, SOUTH AFRICA SAUDI ARABIA, RUSSIAN FEDERATION , POLAND, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MARTINIQUE, MACAU, LEBANON, KUWAIT, REPUBLIC OF KOREA, JAPAN, ITALY, ISRAEL, IRAN, INDONESIA, INDIA, GREECE, GERMANY, FRANCE , CHINA, CANADA, BULGARIA, BRAZIL BELGIUM, BELARUS and AUSTRALIA.
  • Product Description
    GE, Innova¿ 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. || Innova¿ 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities.
  • 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