Recall of Device Recall GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM

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
    57591
  • Event Risk Class
    Class 2
  • Event Number
    Z-2214-2011
  • Event Initiated Date
    2011-01-19
  • Event Date Posted
    2011-05-19
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2012-07-10
  • Event Source
    USFDA
  • Event Source URL
  • 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, x-ray, tomography, computed - Product Code JAK
  • Reason
    Ge healthcare has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain brightspeed systems (brightspeed excel/edge/elite select and brightspeed elite computed tomography x-ray systems ) if this event were to occur on your system, patient safety may be impacted.
  • Action
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION GE Ref: 22932" letter dated January 19, 2011 to its consignees/customers. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction, Contact Information, and Additional Dosimetric Information. A second letter dated March 11, 2011 was sent to the consignee/customer letter consisting of a cover letter and an attachment. "This letter is to notify you of an error in the January 19, 2011, Urgent Medical Device Correction Letter, that you have already received (GE Ref: 22932). In the Safety Issue section of that letter it is written: "If this issue were to occur, it would result in the remainder of the exposure being delivered at the patient position where the table stopped up to the prescribed scan time or 30 seconds, whichever is shorter." The stated 30 seconds limitation is incorrect for your particular model. This information has been corrected on the attached Urgent Medical Device Correction letter, so please discard the original letter if it is still in your possession. " GE Healthcare will provide a software update for all affected systems to address the issue. A GE Healthcare service representative will contact you to arrange for this correction. The customers were also instructed as follows: prior to GE's installation of a software update, continue to monitor patient scanning closely. Should the table stop unexpectedly and X-ray remains on, manually stop the scan, and ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. If you have any questions, please contact GE immediately at the following: United States: 800-437-1171; Japan: 0120-055-919; Korea: 1544-6119; Australia/New Zealand: 800-659-465 and China: 800-810-8188. For other countries please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notifi

Device

  • Model / Serial
    SERIAL  00000231382HM3 00000023378HM0 00000026180YC0 00000026454YC9 00000026731YC0 00000027157YC7 00000027449YC8 00000027452YC2 00000027453YC0 00000027686YC5 00000028252YC5 00000028254YC1 00000222727HM0 00000227688HM9 00000228343HM0 00000228344HM8 00000229115HM1 00000229117HM7 00000229777HM8 00000230875HM7 00000230876HM5 00000233120HM5 00000233775HM6 00000233776HM4 00000233777HM2 00000233778HM0 00000233779HM8 00000234401HM8 00000234402HM6 00000234403HM4 00000235055HM1 00000235351HM4 00000235353HM0 00000235356HM3 00000235357HM1 00000235790HM3 00000236520HM3 00000236521HM1 00000237191HM2 00000237192HM0 00000237945HM1 00000238307HM3 00000238310HM7 00000238691HM0 00000239959HM0 00000239960HM8 00000240263HM4 00000240264HM2 00000241406HM8 00000241410HM0 00000242443HM0 00000242897HM7 00000242900HM9 00000242901HM7 00000243389HM4 00000243392HM8 00000243918HM0 00000243987HM5 00000244184HM8 00000244186HM3 00000244187HM1 00000244444HM6 00000244900HM7 00000244901HM5 00000244902HM3 00000244903HM1 00000244905HM6 00000244912HM2 00000246077HM2 00000247806HM3 00000247808HM9 00000248444HM2 00000248881HM5 00000248885HM6 00000249564HM6 00000249565HM3 00000249567HM9 00000249568HM7 00000249569HM5 00000249572HM9 00000249573HM7 00000249574HM5 00000249575HM2 00000249576HM0 00000249577HM8 00000250128HM6 00000250130HM2 00000250132HM8 00000250133HM6 00000250135HM1 00000250139HM3 00000250143HM5 00000251029HM5 00000251282HM0 00000251283HM8 00000251284HM6 00000251397HM6 00000252095HM5 00000252096HM3 00000252097HM1 00000253328HM9 00000253330HM5 00000253331HM3 00000253337HM0 00000253338HM8 00000253346HM1 00000255464HM0 00000256201HM5 00000256623HM0 00000257360HM8 00000257361HM6 00000257363HM2 00000257364HM0 00000257369HM9 00000257373HM1 00000258371HM4 00000258574HM3 00000259698HM9 00000259938HM9 00000259943HM9 00000260494HM0 00000245520HM2 00000237827HM1 00000252063HM3 00000247809HM7 00000248355HM0 00000248526HM6 00000248527HM4 00000249931HM7 00000246524HM3 00000232142HM0 00000238305HM7 00000231383HM1 00000232143HM8 00000234400HM0 00000239137HM3 00000239453HM4 00000248886HM4 00000250131HM0 00000252917HM0 00000255484HM8 00000258576HM8 00000227690HM5 00000256130HM6 00000226709HM4 00000228702HM7 00000228703HM5 00000229114HM4 00000229116HM9 00000229118HM5 00000229776HM0 00000229778HM6 00000231384HM9 00000236278HM8 00000241411HM8 00000241412HM6 00000242896HM9 00000245521HM0 00000245525HM1 00000247969HM9 00000248445HM9 00000248446HM7 00000248447HM5 00000248448HM3 00000248883HM1 00000248884HM9 00000249562HM0 00000250140HM1 00000251399HM2 00000252062HM5 00000252064HM1 00000252916HM2 00000253341HM2 00000253344HM6 00000253348HM7 00000255349HM3 00000255350HM1 00000256200HM7 00000256622HM2 00000258533HM9 00000240938HM1 00000253342HM0 00000026178YC4 00000229779HM4 00000229780HM2 00000235358HM9 00000239454HM2 00000246523HM5 00000248524HM1 00000248529HM0 00000252065HM8 00000252339HM7 00000252343HM9 00000252977HM4 00000255348HM5 00000256625HM5 00000256851HM7 00000257618HM9 00000257622HM1 00000257662HM7 00000256852HM5 00000242898HM5 00000239958HM2 00000235355HM5 00000257365HM7 00000246063HM2 00000249878HM0 00000249879HM8 00000249880HM6 00000249881HM4 00000256850HM9 00000027456YC3 00000229774HM5 00000230877HM3 00000235354HM8 00000256630HM5 00000258578HM4 00000245528HM5 00000246079HM8 00000234398HM6 00000240937HM3 00000244907HM2 00000025325YC2 00000025358YC3 00000025359YC1 00000025360YC9 00000025361YC7 00000025362YC5 00000025363YC3 00000025364YC1 00000025365YC8 00000025366YC6 00000025367YC4 00000025619YC8 00000025620YC6 00000025621YC4 00000025915YC0 00000025916YC8 00000025978YC8 00000026174YC3 00000026175YC0 00000026176YC8 00000026177YC6 00000026179YC2 00000026181YC8 00000026182YC6 00000026455YC6 00000026456YC4 00000026727YC8 00000026728YC6 00000026729YC4 00000026730YC2 00000026732YC8 00000026733YC6 00000026909YC2 00000026910YC0 00000026911YC8 00000026912YC6 00000026913YC4 00000026914YC2 00000026915YC9 00000027150YC2 00000027151YC0 00000027152YC8 00000027153YC6 00000027154YC4 00000027155YC1 00000027156YC9 00000027158YC5 00000027159YC3 00000027448YC0 00000027450YC6 00000027451YC4 00000027454YC8 00000027455YC5 00000027687YC3 00000027688YC1 00000028251YC7 00000028253YC3 00000028347YC3 00000028350YC7 00000220657HM1 00000220658HM9 00000228704HM3 00000230874HM0 00000231381HM5 00000231385HM6 00000235056HM9 00000235352HM2 00000236272HM1 00000236275HM4 00000238308HM1 00000238690HM2 00000242438HM0 00000242439HM8 00000242440HM6 00000243395HM1 00000244904HM9 00000244906HM4 00000245527HM7 00000246067HM3 00000248449HM1 00000249570HM3 00000250134HM4 00000250142HM7 00000251278HM8 00000251279HM6 00000251280HM4 00000253345HM3 00000256629HM7 00000234399HM4 00000236273HM9 00000240936HM5 00000242899HM3 00000243986HM7 00000244185HM5 00000244910HM6 00000245522HM8 00000246078HM0 00000246522HM7 00000249882HM2 00000251400HM8 00000255480HM6 00000256129HM8 00000256916HM8 00000258577HM6 00000249563HM8 00000250129HM4 00000250542HM8 00000027685YC7 00000249929HM1 00000256909HM3 00000227689HM7 00000230472HM3 00000235359HM7 00000235360HM5 00000241409HM2 00000242441HM4 00000242442HM2 00000243919HM8 00000248528HM2 00000248882HM3 00000249928HM3 00000251285HM3 00000251286HM1 00000251287HM9 00000253332HM1 00000255481HM4 00000256628HM9 00000257366HM5 00000258532HM1 00000258534HM7 00000253339HM6 00000253340HM4 00000239455HM9 00000246476HM6 00000229781HM0 00000236276HM2 00000236277HM0 00000238306HM5 00000244899HM1 00000250137HM7 00000251398HM4 00000252340HM5 00000252342HM1 00000252915HM4 00000256131HM4 00000257619HM7 00000220659HM7 00000223357HM5 00000226708HM6 00000227288HM8 00000227687HM1 00000228342HM2 00000229775HM2 00000230471HM5 00000233121HM3 00000233122HM1 00000236274HM7 00000237193HM8 00000237825HM5 00000237826HM3 00000237946HM9 00000238309HM9 00000238689HM4 00000238692HM8 00000240265HM9 00000240266HM7 00000240934HM0 00000240935HM7 00000240939HM9 00000243390HM2 00000243391HM0 00000243394HM4 00000243396HM9 00000243397HM7 00000244183HM0 00000244908HM0 00000244909HM8 00000244911HM4 00000244913HM0 00000245523HM6 00000245524HM4 00000245526HM9 00000246474HM1 00000247970HM7 00000249537HM2 00000249566HM1 00000249578HM6 00000251339HM8 00000252098HM9 00000252099HM7 00000252100HM3 00000252341HM3 00000253327HM1 00000253335HM4 00000253343HM8 00000255346HM9 00000255347HM7 00000256136HM3 00000256199HM1 00000256416HM9 00000256624HM8 00000256627HM1 00000256917HM6 00000257362HM4 00000257368HM1 00000257624HM7 00000258575HM0 00000258694HM9 00000259601HM3 00000259697HM1 00000260607HM7 00000249930HM9 00000255460HM8 00000027684YC0 00000253329HM7 00000253336HM2 00000247807HM1 00000248525HM8 00000250535HM2 00000250536HM0 00000250537HM8 00000250538HM6 00000252060HM9 00000252061HM7 00000255483HM0 00000256853HM3 00000256854HM1 00000257620HM5 00000257621HM3 00000257623HM9 00000259591HM6 00000232144HM6 00000241408HM4 00000243393HM6 00000252914HM7 00000252918HM8 00000253334HM7 00000255482HM2 00000257367HM3 00000241405HM0 00000248879HM9 00000248880HM7 00000249571HM1 00000250136HM9 00000258573HM5 00000230878HM1 00000248878HM1 00000241407HM6 00000250138HM5 00000250141HM9 00000251281HM2 00000253333HM9 00000253347HM9 00000256132HM2 00000256140HM5 00000227287HM0 00000246475HM8
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states: AL, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MI, MN, MS, MO, NE, NH, NJ, NM, NY, NC, OH, PR, RI, SC, SD, TN, TX, and WV; and countries including: URUGUAY, TURKEY, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, PUERTO RICO, PORTUGAL, POLAND, PARAGUAY, NEW ZEALAND, NETHERLANDS, MEXICO, MARTINIQUE, LEBANON, JAPAN, ITALY, INDONESIA, INDIA, HUNGARY, GREECE, GERMANY, FRANCE, EGYPT, COLOMBIA, CHINA, CHILE, BRAZIL, BELGIUM, BELARUS, BAHRAIN, AUSTRALIA, ANGOLA, ALGERIA. TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, PHILIPPINES, PARAGUAY, OMAN, NEW ZEALAND, MOROCCO, KUWAIT, KAZAKHSTAN, ISLAMIC REPUBLIC OF IRAN, ARGENTINA.
  • Product Description
    BrightSpeed Excel Select, BrightSpeed Edge Select ,BrightSpeed Elite Select and BrightSpeed Elite Computed Tomography X-ray systems with software version 09BW35.11 or 09HW30.4. || The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, for patients of all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast.
  • Manufacturer

Manufacturer

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