Events

Rappel de Straumann coDiagnostiX

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 Straumann Manufacturing 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
    59797
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3184-2011
  • Date de mise en oeuvre de l'événement
    2011-08-04
  • Date de publication de l'événement
    2011-09-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103755
  • 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
    Software version 8.0 has a software anomaly, in which the length is not adjusted accordingly when it is changed after the surgical sleeve position planning step has been completed.
  • Action
    Staumann USA notified accounts by an Urgent Field Safety Notice letter dated August 4, 2011 and delivered via Federal Express Delivery Service. The letter identified the affected product and explained the reason for the recall. Customers were asked to review the letter, take appropriate actions, including completing and faxing the enclosed. Customer Confirmation Form. Straumann released a corrected software upgrade (coDiagnostiX 8.0.2.3672), which is available for download when users go online and activate current software. If the user does not have internet access a replacement CD can be ordered from Technical Support at 866 - 531 -7365. Questions should be directed to Technical Support Monday through Friday from 8:00 am to 8:00 pm Eastern Time.

Device

Straumann coDiagnostiX
  • Modèle / numéro de série
    Software version 8.0 as listed below: listed are the affected articles. Internet Upgrade: 019,0385 @ Upgrade cDX 8 PPP (7+) 019,0386 @ Upgrade cDX 8 Station (7+) 019.0387 @ Upgrade cDx 8 coDoctor (7+) 019.0388 @ Upgrade cDX coDoctor (7+) > PPP 8 0'19.0389 @ Upgrade cDX codoctor (7+) > PPG 8 019.0390 @ Upgrade cDX coDoctor (7+) >Station 8 019.0391 @ Upgrade cDX PPP (7 +):> PPG 8 019.0392 @ Upgrade cDX PPP (7+):> Station 8 019.0393 @ Upgrade coDX PPP > Station 8 Offline Upgrades: 019.0378 Upgrade coDiagnostix 8 PPP (7-) 0'19.0379 Upgrade coDiagnostiX 8 Station (7-) 019.0380 Upgrade coDiagnostiX 8 coDoctor (7-) 019.0381 Upgrade coDoctor (7-) -> PPP 8 019.0382 Upgrade coDoctor (7-) -> PPG8 019.0383 Upgrade PPP (7-) -> PPG 8 019.0384 coDiagnostiX CD coDlagnostiX licenses: 019.0370 coDiagnostiX 8 PPP 019.0371 coDiagnostiX 8 PPG 0'19.0372 coDiagnostiX 8 Station, and  019.0373 coDiagnositX 8 coDoctor.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Straumann coDiagnostiX, version 8.0, used to guide a clinician in the proper implant selection, oral placement and the proper selection of an oral drill. || Imaging processing System
  • Manufacturer
    Straumann Manufacturing Inc.

Manufacturer

Straumann Manufacturing Inc.
  • Adresse du fabricant
    Straumann Manufacturing Inc., 60 Minuteman Rd, Andover MA 01810-1008
  • Source
    USFDA