Events

Recall of Device Recall GE Healthcare Signa Ovation 0.35T

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
    51314
  • Event Risk Class
    Class 2
  • Event Number
    Z-1722-2009
  • Event Initiated Date
    2008-11-03
  • Event Date Posted
    2009-08-25
  • 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=79750
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • Reason
    Ge healthcare has identified a potential pinch point hazard on ovation mr scanner when using ctl array xl body flex and opened body coil. a patient's hand may be pinched between the magnet bore ceiling cover and the ctl array, xl body flex, or open body coil if the patient puts his/her hand on the top of the coil. 2/20/09: recall being expanded to include the openspeed systems.
  • Action
    GE Healthcare issued a "Product Safety Notification" letter dated October 23, 2008. The letter was addressed to Hospital Administrators, Mangers of Radiology/Cardiology & Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information for the Signa Ovation 0.35T Systems. A second GE Healthcare "Urgent Medical Device Correction" letter dated March 5, 2009 was sent 3/9/09 to consignees which addressed the expanded recall to the Signa OpenSpeed0.7T MR Systems. For further questions, contact your local GE Healthcare sales or service representative.

Device

Device Recall GE Healthcare Signa Ovation 0.35T
  • Model / Serial
    Model Number: 2276937;   Serial Numbers: 00000869965YM4, 00000801207YM2, 00000813952YM9, 00000952559YM3, 00000236062MR6, 00000869966YM2, 00000801206YM4, 00000813945YM3, 00000813950YM3, 00000869958YM9, 00000952561YM9, 00000813958YM6, 00000919518YM1, 00000813944YM6, 00000837353YM2, 00000813960YM2, 00000837350YM8, 00000264247MR1, 00000897708YM4, 00000897716YM7, 00000919512YM4, 00000919526YM4, 00000026540VE5, 00000919509YM0, 00000813959YM4, 00000801204YM9, 00000813947YM9, 00000952560YM1, 00000952565YM0, 00000897711YM8, 00000897717YM5, 00000919515YM7, 00000952552YM8, 00000813951YM1, 00000897701YM9, 00000869949YM8, 00000837359YM9, 00000919519YM9, 00000813946YM1, 00000869956YM3, 00000897706YM8, 00000952563YM5, 00000869947YM2, 00000801199YM1, 00000801193YM4, 00000837362YM3, 00000952548YM6, 00000952549YM4, 00000837360YM7, 00000952547YM8, 00000837346YM6, 00000869952YM2, 00000869954YM8, 00000919514YMO, 00000919524YM9, 00000837358YM1, 00000919521YM5, 00000869962YM1, 00000919513YM2, 00000897705YM0, 00000952555YM1, 00000813943YM8, 00000869961YM3, 00000813956YM0, 00000801203YM1, 00000801208YM0, 00000801209YM8, 00000813948YM7, 00000813953YM7, 00000813954YM5, 00000837347YM4, 00000837351YM6, 00000837352YM4, 00000837354YM0, 00000837357YM3, 00000837361YM5, 00000837363YM1, 00000837364YM9, 00000837365YM6, 00000869950YM6, 00000869951YM4, 00000869953YM0, 00000869955YM5, 00000869957YM1, 00000869960YM5, 00000869963YM9, 00000897698YM7, 00000897699YM5, 00000897700YM1, 00000897702YM7, 00000897703YM5, 00000897704YM3, 00000897707YM6, 00000897715YM9, 00000919507YM4, 00000919510YM8, 00000919516YM5, 00000919517YM3, 00000919520YM7, 00000919523YM1, 00000952550YM2, 00000952553YM6, 00000952557YM7, 00000952558YM5, 00000952562YM7, 00000952566YM8, 00000952554YM4, 00000919511YM6, 00000869948YM0, 00000897714YM2, 00000813957YM8, 00000813955YM2, 00000897712YM6, 00000813949YM5;   Model Number: 5118172;  Serial Numbers; 00000000564YR5, 00000000565YR2, 00000000563YR7, 00000000561YR1;  Model Number: 2377062-2;  Serial Number: 00000963007YM0;  Model Number: 2377062-5;  Serial Numbers: 00000000120YR6, 00000000123YR0, 00000000132YR1, 00000000124YR8, 00000000137YR0, 00000000130YR5, 00000000134YR7, 00000000138YR8, 00000962592YM2, 00000000146YR1, 00000000117YR2, 00000000116YR4, 00000000118YR0, 00000943610YM6, 00000000152YR9, 00000000140YR4, 00000000110YR7, 00000000135YR4, 00000000106YR5, 00000000129YR7, 00000000141YR2, 00000000125YR5, 00000000142YR0, 00000000113YR1, 00000000150YR3, 00000000105YR7, 00000000131YR3, 00000000139YR6, 00000000155YR2, 00000000108YR1, 00000000143YR8, 00000000101YR6, 00000000109YR9, 00000000153YR7, 00000951021YM5, 00000000119YR8, 00000000136YR2, 00000000128YR9, 00000000100YR8, 00000000112YR3, 00000000121YR4, 00000000154YR5;  Model Number: 2377062-8;  Serial Numbers: 00000000776YR5, 00000000792YR2, 00000000793YR0, 00000000801YR1, 00000000803YR7, 00000000829YR2, 00000000836YR7, 00000000758YR3, 00000000765YR8, 00000000755YR9, 00000000756YR7, 00000000774YR0, 00000000784YR9, 00000000785YR6, 00000000798YR9, 00000000827YR6, 00000000816YR9, 00000000779YR9, 00000000828YR4, 00000000789YR8, 00000000838YR3, 00000000773YR2, 00000000788YR0, 00000000796YR3, 00000000763YR3, 00000000766YR6, 00000000767YR4, 00000000787YR2, 00000000790YR6, 00000000800YR3, 00000000834YR2, 00000000840YR9, 00000000830YR0, 00000000832YR6, 00000000786YR4, 00000000764YR1, 00000000775YR7, 00000000818YR5, 00000000768YR2, 00000000757YR5, 00000000760YR9, 00000000762YR5, 00000000783YR1, 00000000809YR4, 00000000782YR3, 00000000812YR8, 00000000826YR8, 00000000835YR9, 00000000770YR8, 00000000771YR6, 00000000825YR0, 00000000759YR1, 00000000821YR9, 00000000841YR7, 00000000831YR8, 00000000808YR6, 00000000823YR5, 00000000824YR3, 00000000772YR4, 00000000810YR2, 00000000837YR5, 00000000769YR0, 00000000815YR1, 00000000833YR4, 00000000804YR5, 00000000778YR1, 00000000780YR7, 00000000795YR5, 00000000799YR7, 00000000805YR2, 00000000807YR8, 00000000819YR3, 00000000839YR1, 00000000811YR0, 00000000761YR7, 00000000777YR3, 00000000781YR5, 00000000791YR4, 00000000797YR1, 00000000794YR8; and  Model Number: 5148725;  Serial Numbers: 00000154413HM9, 00000176551HM0, 00000139846HM0, 00000192389HM5, 00000177143HM5, 00000193109HM6, 00000148905HM3, 00000147526HM8, 00000138166HM4, 00000000SPI275, 00000188489HM9, 00000167482HM9, 00000169104HM7, 00000171692HM7, 00000157419HM3, 00000266430MR8, 00000155516HM8, 00000155515HM0, 00000160809HM0, 00000175023HM1, 00000150718HM5, 00000162563HM1, 00000164072HM1, 00000165772HM5, 00000172421HM0, 00000172816HM1, 00000172869HM0, 00000173908HM5, 00000177792HM9, 00000178519HM5, 00000179361HM1, 00000180127HM3, 00000180746HM0, 00000182071HM1, 00000182249HM3, 00000182597HM5, 00000183130HM4, 00000187365HM2, 00000188810HM6, 00000189105HM0, 00000191017HM3, 00000191154HM4, 00000196647HM2, 00000200577HM5, 00000265078MR6, 00000157418HM5, 00000174348HM3, 00000189943HM4, 00000181736HM0, 00000146891HM7, 00000158641HM1, 00000147906HM2, 00000169833HM1, 00000170940HM1, 00000190359HM0, 00000191544HM6, 00000193220HM1, 00000193936HM2, 00000195772HM9, 00000144797HM8, 00000150152HM7, 00000170109HM3, 00000181735HM2, 00000197645HM5, 00000168323HM4 and 00000181517HM4.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-- US (including states of AL, ALZ, AR, CA, CO,CT, DE, FL, FA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MT, MO, NE,NH, NV, NJ, NY, NC, OH, OK, OR, PA, PR, SC SD, TN, TX, VA, WA, WV and WI), CHINA, CYPRUS, ARGENTINA, BRAZIL EGYPT, DENMARK, FEDERAL REPUBLIC OF GERMANY, FEDERAL REPUBLIC OF FRANCE, GET 7 D CHINA, GREECE, HUNGARY, ITALY, IVORY COAST, JAPAN, KOREA, KUWAIT, MALAWI, MEXICO, OMAN, PANAMA, PHILIPPINES, RUSSIAN FEDERATION, SAUDI ARABIA, SPAIN , SWITZERLAND, TURKEY, UKRAINE, UNITED ARAB EMERITUS, UNITED KINGDOM and VENEZUELA.
  • Product Description
    GE Healthcare Signa Ovation 0.35T, Model Numbers: || Ovation 1-3 (2276937), Ovation 4 (2377062-2, 2377062-5, 2377062-8, or 5118172), and Ovation 5 (5148725). || The 0.35T Signa Ovation with Excite Magnetic Resonance system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The 0.35T Signa Ovation with Excite Magnetic Resonance system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the body including, but not limited to, the musculoskeletal, vascular, cardiac, and neuron systems.
  • 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