Events

Rappel de Device Recall Pressure Imaging System

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 Xsensor Technology Corporation.

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
    54229
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0919-2011
  • Date de mise en oeuvre de l'événement
    2009-07-20
  • Date de publication de l'événement
    2011-01-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-01-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87910
  • 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, pressure measurement, intermittent - Product Code JFC
  • Cause
    The plastic enclosures for the x3 display and x3 pro pressure mapping system has a ul94 hb flammability rating while the medical equipment specification ul 60601-1 requires v-2 rated plastic for electronic enclosures.
  • Action
    On July 6, 2009, Xsensor sent an "URGENT: MEDICAL DEVICE RECALL" notifications to their consignees/customers. The consignees/customers were informed that the incorrect material of the plastic enclosures was used. The incorrect plastic had a UL94 HB flammability rating while the medical equipment specification UL 60601-1 required V-2 rated plastic for electronic enclosures. The firm provided prepaid shipping box to consignees/customers with instructions for returning the components. The components were refurbished and returned to consignees for free of charge. For further information please contact XSENSORs Customer Support at 1-866-927-5222.

Device

Device Recall Pressure Imaging System
  • Modèle / numéro de série
    Serial numbers for X3 display: CTDPDA00 S2000 R04, CTDPDA00 S2001 R04, CTDPDA00 S2002 R04, CTDPDA00 S2003 R04, CTDPDA00 S2004 R04, CTDPDA00 S2005 R04, CTDPDA00 S2006 R04, CTDPDA00 S2007 R04, CTDPDA00 S2013 R04, CTDPDA00 S2016 R04, CTDPDA00 S2017 R04, CTDPDA00 S2021 R04, CTDPDA00 S2022 R04, CTDPDA00 S2024 R04, CTDPDA00 S2025 R04, CTDPDA00 S2026 R04, CTDPDA00 S2027 R04, CTDPDA00 S2028 R04, CTDPDA00 S2030 R04, CTDPDA00 S2032 R04, CTDPDA00 S2035 R05, CTDPDA00 S2036 R05, CTDPDA00 S2037 R05, CTDPDA00 S2038 R05, CTDPDA00 S2039 R05, CTDPDA00 S2040 R05, CTDPDA00 S2041 R05, CTDPDA00 S2042 R05, CTDPDA00 S2043 R05, CTDPDA00 S2044 R05, CTDPDA00 S2045 R05, CTDPDA00 S2050 R05, and CTDPDA00 S2054 R05.   Serial numbers for X3 PRO: CMUHUB00 S2023 R05 and CMUHUB00 S2033 R05.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Devices were distributed to one distributor, medical facilities, and rehab centers through out the US, including following states: AL, AR, AZ, CA, CO, FL, GA, IA, IL, KS, ME, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, and WI.
  • Description du dispositif
    Product labeling of the X3 Display reads in part: || "XSENSOR Technology Corporation***X3 DISPLAY*** REF: XBOM-002 PID: CTDPDA00 S*** R***60601-1 61010-1***Calgary, AB, CANADA***Made in Canada". || Product labeling of the X3 PRO reads in part: || "XSENSOR Technology Corporation***X3 PRO***REF:XBOM-004 PID: CMUHUB00 S***R***60601-1 61010-1***Calgary, AB, CANADA***Made in Canada". || Pressure mapping and surface assessment for seats, seat backs, and beds. XSENSOR pressure imaging systems, also known as pressure mapping systems, are a valuable tool in helping clinicians prevent and manage pressure ulcers. Clinicians, nurses, and rehabilitation specialists use XSENSOR pressure imaging systems to help prevent pressure ulcers through improved surface selection and patient positioning on wheelchairs and hospital beds.
  • Manufacturer
    Xsensor Technology Corporation

Manufacturer

Xsensor Technology Corporation
  • Adresse du fabricant
    Xsensor Technology Corporation, 111 319 2nd Ave Sw, Calgary Canada
  • Société-mère du fabricant (2017)
    Xsensor Technology Corporation
  • Source
    USFDA