Events

Rappel de Device Recall GE Centricity PACS 3.2

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.

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
    64784
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1214-2015
  • Date de mise en oeuvre de l'événement
    2013-02-18
  • Date de publication de l'événement
    2015-02-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-05-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117065
  • 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, image processing, radiological - Product Code LLZ
  • Cause
    Using merge exam in single study mode may result in missing study record (cannot display exam, send exam, etc). exam merge in single study mode may fail on &amp.
  • Action
    Consignees were notified of the issue via telephone and site visit by GE Healthcare IT Field Engineers.

Device

Device Recall GE Centricity PACS 3.2
  • Modèle / numéro de série
    Catalog Number and Catalog Description:  K2000YS , HCA 3.2 UPGRADE KIT (LX) ; K2000YT , HCA 3.2 UPGRADE KIT (S2L) ; K20241SG , C 3.2 TECH S/W CONCURRENT ; K20241SH , C 3.2 DIAG S/W CONCURRENT ; K20241SJ , C 3.2 CLIN S/W CONCURRENT ; K20241SK , C 3.2 TECH S/W SEAT ; K20241SL , C 3.2 DIAGNOSTIC S/W SEAT ; K20241SM , C 3.2 CLINICAL S/W SEAT ; K20241TS , CPACS SOL 2.1 TO LIN 4.0 ; K20241TT , CPACS SOL 3.X TO LIN 4.0 ; K20241TW , CPACS LIN 3.X TO LIN 4.0 ; K20241TY , CPACS LIN 2.X TO LIN 4.0 ; K2024SG , C 3.2 TECH S/W CONCURRENT ; K2024SH , C 3.2 DIAG S/W CONCURRENT ; K2024SJ , C 3.2 CLIN S/W CONCURRENT ; K2024SK , C 3.2 TECH S/W SEAT ; K2024SL , C 3.2 DIAGNOSTIC S/W SEAT ; K2024SM , C 3.2 CLINICAL S/W SEAT ; K2024TS , CPACS SOL 2.1 TO LIN 4.0 ; K2024TT , CPACS SOL 3.X TO LIN 4.0 ; K2024TW , CPACS LIN 3.X TO LIN 4.0 ; K2024TY , CPACS LIN 2.X TO LIN 4.0 ; K2024WH , CPACS S2.1 TO L4.0 SWOP ; K2024WJ , CPACS S3.X TO L4.0 SWOP ; K2024WK , CPACS L3.X TO L4.0 SWOP ; K2024WL , CPACS L2.X TO L4.0 SWOP ; K20351SM , CPACS SOL 2.1 TO LIN 3.2 ; K20351SN , CPACS SOL 3.X TO LIN 3.2 ; K20351SP , CPACS LIN 2.X TO LIN 3.2 ; K20351SR , CPACS LIN 3.X TO LIN 3.2 ; K20351ZA , CPACS 3.2.X TO 3.2SP7 UPG ; K2035SM , CPACS SOL 2.1 TO LIN 3.2 ; K2035SN , CPACS SOL 3.X TO LIN 3.2 ; K2035SP , CPACS LIN 2.X TO LIN 3.2 ; K2035SR , CPACS LIN 3.X TO LIN 3.2 ; K2035SW , CPACS 3.2 BASE LIC 20K ; K2035ZA , CPACS 3.2.X TO 3.2SP7 UPG ; P2035SW , CPACS 3.2 BASE LIC 20K ; 2079312-001 , ND SW CPACS 3.2 SP8 WS APP WEB DWNLD
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed US (nationwide) including the states of AK, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, and WV, and the country of Bermuda.
  • Description du dispositif
    The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Adresse du fabricant
    GE Healthcare, 540 W Northwest Hwy, Barrington IL 60010-3051
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA