Events

Rappel de Device Recall GE Healthcare Revolution CT

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par GE Healthcare, LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    74196
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1915-2016
  • Date de mise en oeuvre de l'événement
    2016-05-09
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146710
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, x-ray, tomography, computed - Product Code JAK
  • Cause
    Gehc has become aware of a potential safety issue in the revolution ct patient table that can result in unintended motion in cases involving large patients. the revolution ct cradle can descend on its own after activation by the user. this can put the patient at risk for harm. the harm can involve the impinging or crushing of a hand if caught between the cradle and ct inner gantry bore. no injurie.
  • Action
    The firm, GE Healthcare, sent an "Urgent Medical Device Correction" letter ,GEHC Ref# 25468, dated May 9, 2016 to its Consignees. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers & Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. The consignees were instructed to ensure that all potential users in your facility are made aware of this safety notification and the recommended actions; continue to use your Revolution CT product; follow the Patient Positioning warning outlined in the Revolution CT User Manual; to prevent pinching or crushing of the patients extremities, keep the patients hands and feet away from the edge of the moving table top/cradle and its surrounding equipment, or between table base and side panels of the table; and take special care when positioning physically large patients. 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

Device Recall GE Healthcare Revolution CT
  • Modèle / numéro de série
    Mfg Lot or Serial # System ID 00000437624CN0 N/A 00000439694CN1 N/A 00000439777CN4 N/A 00000439930CN9 N/A 00000441224CN3 203688ERREV1 00000441575CN8 N/A 00000441624CN4 N/A 00000441648CN3 N/A 00000441916CN4 469841REVO 00000442032CN9 N/A 00000442124CN4 N/A 00000442219CN2 N/A 00000442443CN8 N/A 00000443993CN1 N/A 00000444530CN0 N/A 00000445085CN4 N/A 00000438756CN9 309655REVCT 00000439113CN2 212241REVCT 00000439205CN6 415476MCT3 00000439287CN4 415476MCT2 00000439836CN8 215662CTREV 00000440713CN6 815226RVCT 00000441459CN5 206320REV 00000441716CN8 808522RCT 00000442228CN3 281274REV 00000442994CN0 919684REVCT 00000443379CN3 608263REVCT 00000443664CN8 409772CT7 00000443900CN6 402481BEREVCT 00000444165CN5 AM14CFI65 00000444175CN4 801507REV 00000444253CN9 704384REV 00000444745CN4 808KMCCT 00000444872CN6 316268REVCT 00000445059CN9 310222REVO 438369CN1 206598REV1 438902CN9 801662REV1 439823CN6 408356RV1 439835CN0 503216SREV 441040cn3 215952CTREV 441064CN3 256HHRCT1 441066CN8 414805REVCT 441262CN3 RMHCTREV 441990CN9 206598ERREV 442592CN2 205699CTREV 442706CN8 727398REVO 443069CN0 404616CTR 443227CN4 940898REVO 443327CN2 858824REVCT 444398CN2 731541REVCT 444409CN7 386REVCT3 444840CN3 760940REVCT 444913CN8 206288SCREV 00000437624CN0 786596WKRIVO 00000439777CN4 703698REVOCT 00000439930CN9 715847RCT1 00000442124CN4 408498RV2 443327CN2 858824REVCT 00000441624CN4 217876REVO1 00000445085CN4 713792ACT35 00000441575CN8 847437ACT7 442032CN9 512DELLCT 00000442994CN0 N/A 3993CN1 972566OPREVO 445084CN7 708216CTREV 442592CN2 AM13KPM21 444165CN5 317338STVREVO 444970CN8 630527REVO 00000436942CN7 83119511730 00000439799CN8 83119074723 00000441381CN1 83130644883 00000441694CN7 83132979115 00000442968CN4 83141966438 00000439505CN9 190059CT06 00000440315CN0 220078CT04 00000441578CN2 030355CT07 00000441683CN0 CT441683CN0 00000443038CN5 CT443038CN5 00000445060CN7 204787RCT1 00000437410CN4 519646REVO1 440051CN1 E416249CT1 441839CN8 E416249CTE 442044CN4 403944RCT1 442094CN9 604988RCT1 442163CN2 416864RCT1 442378CN6 E416249CT2 443342CN1 905521RCT1 441839CN8 N/A 442219CN2 416284CT1 442443CN8 604682RCT1 00000440672CN4 82421040350 00000440940CN5 82421040345 00000440986CN8 82421050106 00000441519CN6 82421040346 00000441805CN9 82421040359 00000441899CN2 82421120479 00000442052CN7 82421030199 00000442479CN2 82421190324 00000442749CN8 82421040369 00000443071CN6 82421300072 00000443167CN2 82421190317 00000443253CN0 82421120484 00000443308CN2 82421040370 00000443741CN4 82421200266 00000444092CN1 82421120524 00000444206CN7 82421160425 00000444243CN0 82421150167 00000444317CN2 N/A 00000444470CN9 82421040372 00000444648CN0 82421100836 00000444706CN6 N/A 00000444712CN4 82421100835 00000444888CN2 82421100846 00000444926CN0 N/A 00000444969CN0 N/A 00000445019CN3 82421130179 00000445199CN3 N/A 00000442412CN3 DK1051CT04 00000444278CN6 EE4019CT05 00000436925CN2 M2322254 00000440136CN0 P4192906 00000441105CN4 X41944012 00000441768CN9 M41980112 00000442256CN4 E4191734 00000442507CN0 M44827197 00000442792CN8 M5480791 00000443967CN5 M2800929 DUMFMI25465B02 CC0618CT08 00000439368CN2 PC3383CT01 00000441210CN2 HC5284CT04 00000443675CN4 410014CT04 00000438247CN9 828210096 00000440778CN9 835210259 00000442887CN6 5973CT0019 00000440478CN6 A5624142 00000443869CN3 A51773126 00000437849CN3 REV001 00000439234CN6 REV006 00000439407CN8 REV002 00000439537CN2 REV003 00000439754CN3 REV004 00000439931CN7 REV008 00000440024CN8 REV005 00000440622CN9 REV007 00000441177CN3 REV009 00000441322CN5 REV011 00000441959CN4 REV012 00000442334CN9 REV020 00000442785CN2 REV015 00000443471CN8 REV014 00000443501CN2 REV013 00000445156CN3 REV022 00000444523CN5 N/A 00000442622CN7 850210885 00000442940CN3 850210884 00000443590CN5 850210890 00000445179CN5 N/A 00000441549CN3 KW1098CT01 00000442802CN5 KW1011CT03 00000444791CN8 KW1011CT04 00000444110CN1 CT444110CN01 00000439632CN1 85109909185 00000442289CN5 NO1031CT01 00000442868CN6 NO1146CT02 00000445041CN7 N/A 00000442748CN0 CT442748CN0 00000444156CN4 CT444156CN4 00000439834CN3 PL1008CT04 00000440221CN0 PL1150CT03 00000440441CN4 SA1012CT10 00000443703CN4 N/A 00000444345CN3 N/A 00000444375CN0 SA1012CT12 00000443956CN8 6073CT0013 00000443448CN6 DPN88638 00000444082CN2 MPX30114 00000439660CN2 D007CT07 00000440739CN1 A010CT16 00000441292CN0 A010CT17 00000443380CN1 A201CT02 00000443400CN7 A201CT01 00000443540CN0 A201CT03 00000443952CN7 R002CT09 00000444016CN0 A007CT04 00000444672CN0 N/A 00000438438CN4 900010CT06 00000439169CN4 260010CT19 00000443556CN6 260010CT20 00000442350CN5 853210292 00000438994CN6 AE1477CT01 00000444038CN4 AE1015CT02 DUMFMI25465B01 00216CTS13 00000440706CN0 00160CTS03 00000440906CN6 00487CTS03 00000440928CN0 00243CTS11 00000443409CN8 00145CTS01 00000443994CN9 00095CTS04
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AL, CA, CT, FL, GA, HI, IL, IN, KS, NE, NY,NC, OH, OR, PA, TN, TX, UT, A, WA, WI; and countries of: Australia, Belgium, Brazil, Canada, China, Denmark, Estonia, France, Germany, Hong Kong, Indonesia, Italy, Japan, Korea (Republic of), Kuwait, Mexico, New Zealand, Norway, Peru, Poland, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and United Kingdom.
  • Description du dispositif
    GE 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 Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA