Events

Rappel de Device Recall SwitchPoint Infinity Control 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 Stryker Communications Corp.

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
    59866
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0136-2012
  • Date de mise en oeuvre de l'événement
    2011-08-23
  • Date de publication de l'événement
    2011-10-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103891
  • 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
    Light, surgical, ceiling mounted - Product Code FSY
  • Cause
    Installation records for the switchpoint infinity, booms, lights, and flat panel systems are incomplete or inadequate.
  • Action
    Stryker sent an URGENT FIELD SAFETY NOTICE: RA2010-245 dated August 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the attached Customer Response Form within 5 business days to Stryker. A Stryker representative would contact them at their convenience to schedule a re-inspection for all of the units identified and still in use. In the event the inspected equipment does not meet Stryker's established specifications, their representative will visit their facility and hopefully resolve the issue. If a subsequent visit is required the date will be scheduled in full consideration of their services. For questions regarding this recall call 972-410-7310.

Device

Device Recall SwitchPoint Infinity Control System
  • Modèle / numéro de série
    Catalog numbers: 0678000530, 0678000531, 0678000532, 0678000533, 0678000534, 0678000535, 0678000536, and 0678000537. Serial Numbers: All product distributed and installed between July 2004 and March 2011.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including Puerto Rico, Brazil, Ecuador, Venezuela, Costa Rico, Bolivia, Peru, Mexico, China, India, Korea, Philippines, Singapore, Malaysia, Taiwan, Middle East, Russia, Africa, Poland, South Africa, Australia, New Zealand, Canada, Japan, Denmark, Finland, Norway, Sweden, Belgium, The Netherlands, France, Germany, Austria, Italy, Portugal, Spain, Romania, Switzerland, and United Kingdom.
  • Description du dispositif
    SwitchPoint Infinity Control System || Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208 || The SwitchPoint Infinity (SPI) Control System is an integrated voice, video, data router and teleconferencing interface for operating rooms. The SwitchPoint Infinity is used for direct control of room equipment, audio/video equipment, and indirect control of surgical equipment in the operating room.
  • Manufacturer
    Stryker Communications Corp

Manufacturer

Stryker Communications Corp
  • Adresse du fabricant
    Stryker Communications Corp, 1410 Lakeside Pkwy Ste 100, Flower Mound TX 75028-4026
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA