Events

Rappel de Device Recall IMRIS ORT200 Removable Operating Room Table

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 Deerfield Imaging, Inc..

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
    79366
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1217-2018
  • Date de mise en oeuvre de l'événement
    2018-02-23
  • 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=162136
  • 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
    Table, operating-room, ac-powered - Product Code FQO
  • Cause
    The rotational locking mechanisms on the ort 200/300 tables fail to operate such that it cannot change states between locked and unlocked.
  • Action
    The firm disseminated their notices on 02/23/2018 by mail and followed with an email on 02/26/2018. The notice stated: "It has recently come to our attention that the ORT200/300 rotational lock fails to operate such that it cannot change states between locked and unlocked. This may pose a risk of injury to the patient. To minimize the risk of injury, IMRJS is taking the following corrective actions: " ORT200 and 300 tables: all customer sites with these tables shall have the rotational lock operation verified and adjusted, if necessary. IMRIS has identified that your facility has one or more of these OR Tables which require evaluation. Please confirm details on page 2 and return your response to IMRIS. IMRIS Customer Service will contact you to implement this corrective action. IMRIS recommends these preventive actions: " Per the OAT Operator Manuals the table should be tested daily in all standard positions and inspected for anomalies including the fit of the covers, tabletops, headrest, pendant connection and rotation. " During usage, verify the table is locked by manually pushing the table to make sure it does not move rotationally. " If the rotational lock is observed to be not functioning properly, please contact IMRIS Customer Service. The appropriate competent authorities have been notified of this corrective action. IMRIS is committed to patient and user safety, and apologizes for any inconvenience that this may cause. Please contact customer support via our service line at 1-866-475-0525 or Email: customersupport@imris. com if you have any questions or concerns."

Device

Device Recall IMRIS ORT200 Removable Operating Room Table
  • Modèle / numéro de série
    Serial numbers: 10006997, 10002692, 10006152, 10007192, 10006991, 10002220, 10003754, 10006997, 10004513, 10005201, 10006891, 10004463, 10005189, 10005190, 10004327, 10004997, 10006891
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US, Canada, China, Sweden, Germany, Japan, Qatar, France, Audtralia
  • Description du dispositif
    IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.
  • Manufacturer
    Deerfield Imaging, Inc.

Manufacturer

Deerfield Imaging, Inc.
  • Adresse du fabricant
    Deerfield Imaging, Inc., 5101 Shady Oak Rd S, Minnetonka MN 55343-4100
  • Société-mère du fabricant (2017)
    Deerfield Management Company L.P.
  • Source
    USFDA