Events

Rappel de Device Recall NOVADAQ SPYPHI

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 NOVADAQ TECHNOLOGIES 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
    77901
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3236-2017
  • Date de mise en oeuvre de l'événement
    2017-06-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-12-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158508
  • 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
    Cover, barrier, protective - Product Code MMP
  • Cause
    The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
  • Action
    The recalling firm, Novadaq, issued an "URGENT DEVICE RECALL" letter dated 6/15/2017 via delivery by firm sales representatives or courier service (such as FedEx or UPS) on 6/27/2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to return unused product to Novadaq representative and complete and return the Acknowledgement of Receipt form by email to Novadaq Quality Department at quality@novadaq.com within 24 hours of receipt. Any questions or concerns may also be sent the listed email address. If you have any questions, please do not hesitate to contact the Director of Regulatory Affairs at 1.905.629.3822 ext 205 or email: jpendlebury@novadaq.com.

Device

Device Recall NOVADAQ SPYPHI
  • Modèle / numéro de série
    Lots #1703291, #1704141, and #1704101
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution. US (nationwide) to states of: CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.
  • Description du dispositif
    NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. || The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.
  • Manufacturer
    NOVADAQ TECHNOLOGIES INC.

Manufacturer

NOVADAQ TECHNOLOGIES INC.
  • Adresse du fabricant
    NOVADAQ TECHNOLOGIES INC., 8329 Eastlake Dr Unit 101, Burnaby Canada
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA