Events

Recall of GE Revolution CT 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
    72617
  • Event Risk Class
    Class 2
  • Event Number
    Z-0401-2016
  • Event Initiated Date
    2015-10-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141672
  • 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 recently become aware of a potential issue with routine head scans on your revolution ct scanner. a potential hazardous situation can occur during a routine head scan with possible artifacts that may emulate pathology between the brain tissue and bone in the head images. no injuries have been reported to date related to this issue.
  • Action
    The firm, GE Healthcare, sent an"Urgent Medical Device Correction" letter GEHC Ref#25465 dated October 23, 2015 to its Consignees. The letter described the Safety Issues, Safety Instructions, Product Correction, Affected Product Details and Contact Information. The consignees were instructed to follow the instructions in existing CT User Manual and the safety instructions listed in the letter. GE will be delivering an addendum to the User Manual that reiterates these mitigations. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

GE Revolution CT System
  • Model / Serial
    Mfg Lot or Serial # System ID 00000439632CN1 85109909185 00000439899CN6 83119074723 00000439913CN5 83119511730 00000441487CN6 83130644883 00000441818CN2 83132979115 00000443068CN2 GON-1510990 00000439432CN6 190059CT06 00000440338CN2 220078CT04 00000441574CN1 030355CT07 00000441779CN6 CT441683CN0 00000443105CN2 CT443038CN5 00000440186CN5 E416249CT1 00000437461CN7 519646REVO1 00000442492CN5 E416249CT2 00000443398CN3 905521RCT1 441961CN0 E416249CTE 442082CN4 403944RCT1 442220CN0 604988RCT1 442268CN9 416864RCT1 442573CN2 604682RCT1  AM13ECY81 00000440839CN9 82421040350 00000441053CN6 82421040345 00000441107CN0 82421050106 00000441563CN4 82421040359 00000441930CN5 82421040346 00000442030CN3 82421120479 00000442196CN2 82421030199 00000442749CN8 82421040369 00000443203CN5 82421300072 00000443282CN9 82421190317 00000443322CN3 82421120484 00000443348CN8 82421040370 442794CN4 GON-1510879 00000442517CN9 DK1051CT04 00000437837CN8 M2322254 00000440172CN5 P4192906 00000441238CN3 X41944012 00000441687CN1 M2800929 00000441895CN0 M41980112 00000442351CN3 E4191734 00000442588CN0 M44827197 00000442845CN4 M5480791 00000439243CN7 PC3383CT01 00000441264CN9 HC5284CT04 00000438342CN8 828210096 00000440967CN8 835210259 00000442981CN7 5973CT0019 00000439938CN2 A5624142 00000437028CN4 REV001 00000439356CN7 REV006 00000439639CN6 REV003 00000439802CN0 REV002 00000439812CN9 REV004 00000440092CN5 REV008 00000440113CN9 REV005 00000440682CN3 REV007 00000441280CN5 REV009 00000441460CN3 REV011 00000442008CN9 REV012 00000442404CN0 REV020 00000443513CN7 REV014 00000443527CN7 REV013 00000442704CN3 850210885 00000442992CN4 850210884 00000441573CN3 KW1098CT01 00000442961CN9 GON-4291498 00000442923CN9 NO1146CT02 00000442774CN6 GON-1505695 00000439901CN0 PL1008CT04 00000440335CN8 PL1150CT03 00000440624CN5 SA1012CT10 00000443519CN4 GON-4326652 00000439695CN8 D007CT07 00000440805CN0 A010CT16 00000441378CN7 A010CT17 00000443442CN9 GON-1505146 00000443455CN1 GON-4289981 00000443526CN9 GON-4289991 00000438864CN1 900010CT06 00000439199CN1 260010CT19 00000443665CN5 GON-4320212 00000442509CN6 853210292 00000439068CN8 AE1477CT01 00000440886CN0 00160CTS03 00000440887CN8 00243CTS11 00000441017CN1 00487CTS03 00000443477CN5 GON-4326453 00000437787CN5 786596WKRIVO 00000438503CN5 206598REV1 00000438951CN6 309655REVCT 00000439029CN0 801662REV1 00000439160CN3 212241REVCT 00000439367CN4 415476MCT3 00000439394CN8 415476MCT2 00000439736CN0 940898REVO 00000439838CN4 703698REVOCT 00000439977CN0 408356RV1 00000440004CN0 503216SREV 00000440030CN5 215662CTREV 00000440053CN7 715847RCT1 00000441997CN4 GON-198192509 00000442142CN6 GON-198967538 00000442229CN1 408498RV2 00000442295CN2 GON-201658733 00000443146CN6 919684REVCT 00000443377CN7 8588824REVCT 00000443420CN5 608263REVCT 440707CN8 815226RVCT 441081CN7 808522RCT 441165cn8 256HHRCT1 441199CN7 414805REVCT 441320CN9 RMHCTREV 441520CN4 203688ERREV1 441553cn5 215952CTREV 441647CN5 847437ACT7 441739cn0 217876REVO1 441916CN4 469841REVO 442050CN1 206598ERREV 442300CN0 281274REV 442376CN0 262574REVO 442719cN1 727398REVO  512DELLCT  205699CTREV  AM13NAY127
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AL, CA, CT, FL, GA, HI, IL, NY, NC, OH, OR, PA, TX, UT, VA, WA, WI; and countries of: AUSTRALIA, BELGIUM BRAZIL, CANADA, CHINA,DENMARK, FRANCE, GERMANY, HONG KONG, INDONESIA, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, NORWAY, PERU, POLAND, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    GE Healthcare, Revolution CT Scanners. || Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.
  • 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