Events

Rappel de Device Recall Giraffe Spot PT

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 Ohmeda Medical.

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
    76283
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1503-2017
  • Date de mise en oeuvre de l'événement
    2016-11-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-07-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152636
  • 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
    Unit, neonatal phototherapy - Product Code LBI
  • Cause
    Certain power cords could overheat. the affected power cords were manufactured by electric-cord and are referred to as taller bridge power cords. the overheating of the power cord could result in fire, charring, smoke, or sparking where the power cord connects to the wall outlet which could cause thermal injury.
  • Action
    According to the firm, this issue will be resolved by sending an Urgent Medical Device Correction customer letter to customers with affected Power Cords. This letter will inform the customer of the issue and provide safety instructions for immediate mitigation of the issue. The long-term solution is to re-place all affected Power Cords at no cost to the customer. According to the firm, the plan for public notification is to contact all customers with affected Power Cords by means of an Urgent Medical Device Correction letter. In the US this will be sent by a traceable means (either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX). This letter will be sent to the following titles within the affected accounts; Nurse Managers, Labor & Delivery/NICU, Bio-Medical Engineering Department Managers and Risk Management Directors We will track all service requests for the field action to completion. These service requests will record the replacement of the affected Power Cords. Exceptions to completion of the service request will be recorded as well. Records of field action completion will be retained per our processes and procedures.

Device

Device Recall Giraffe Spot PT
  • Modèle / numéro de série
    See Attached Spreadsheat
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide and Puerto Rico) Bahamas and Internationally to UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras, El Salvador, Ecuador, Costa Rica, Colombia, Canada, Brazil, and Venezuela,
  • Description du dispositif
    Giraffe Spot PT || Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital
  • Manufacturer
    Ohmeda Medical

Manufacturer

Ohmeda Medical
  • Adresse du fabricant
    Ohmeda Medical, 8880 Gorman Rd, Laurel MD 20723-5800
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA