Events

Rappel de Device Recall SSH880CV Aplio Artida

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 Toshiba American Medical Systems 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
    55543
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2203-2011
  • Date de mise en oeuvre de l'événement
    2010-01-06
  • Date de publication de l'événement
    2011-05-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91087
  • 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, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Cause
    Toshiba america medical systems (tams) has become aware that the flex m software has reversed left and right annotation and post flex m measurement error, which may result in incorrect values.
  • Action
    The recall communication was initiated on 1/6/10 with Toshiba forwarding an Urgent: Medical Device Correction letter with attached Customer Notification Reply Form (via US Postal Service for US Customers) to all customers who purchased the FLEX-M mode on Aplio Artida Diagnostic Ultrasound System. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to avoid performing M image measurement using images saved in FLEX-M mode until the corrective action is completed. If customers need to perform measurement for images saved in FLEX-M mode, they were instructed to use manual calibration. Customers were instructed to note that even though the corrective action is taken, the existing saved images (saved images before the corrective action is taken) are not modified. Therefore, when referring to the measured values on the images which are saved in FLEX-M mode before the corrective action is taken, customers were instructed to carefully handle the measurements results because they may be incorrect. Customers were instructed to complete the attached form and fax it to the toll free number at the top of the form. The form can also be sent via e-mail to raffairs@tams.com. If customers have any questions regarding the medical device correction letter, they can contact the Director of Regulatory Affairs at (800) 421-1968 or their local Toshiba representative.

Device

Device Recall SSH880CV Aplio Artida
  • Modèle / numéro de série
    W1A0822031-33, W1A0822048-49, W1A0832056, W1A0842069-70, W1B0852071-80, W1B0862087-8, W1C0872103-08, W1C0882119-24, W1F0972204-06, W1F0972218-20, W1F0992260-62, W1F0992268, and W1F0992270-73.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- Including states of IA, MT, PA, CA, OR, GA, LA, OH, TX, MA, OH, WI, and Puerto Rico.
  • Description du dispositif
    Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound
  • Manufacturer
    Toshiba American Medical Systems Inc

Manufacturer

Toshiba American Medical Systems Inc
  • Adresse du fabricant
    Toshiba American Medical Systems Inc, 2441 Michelle Dr, P.O. Box 2068, Tustin CA 92781-2068
  • Société-mère du fabricant (2017)
    Canon Inc
  • Source
    USFDA