Events

Rappel de Quasar MD

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 Quasar Bio-Tech, Inc. dba Silver Bay LLC.

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
    63530
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0518-2013
  • Date de mise en oeuvre de l'événement
    2012-10-25
  • Date de publication de l'événement
    2012-12-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-05-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114185
  • 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
    Lamp, infrared, therapeutic heating - Product Code ILY
  • Cause
    Quasar bio-tech is recalling their baby quasar, baby quasar pink, quasar power pack, and quasar md because the device is unapproved.
  • Action
    The firm, Quasar Bio-Tech, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated November 16, 2012 to its customers. All domestic customers were notified by Certified mail. The letter described the product, problem and actions to be taken. The customers were instructed to cease distribution and remove the products from sale; to complete and return the enclosed Response Form via e-mail to DeNette@quasarbiotech.com or fax to: Quasar Bio-Tech, Attn: Quality/Recall Coordinator: at 941-306-5816, and return all remaining stock to Quasar Bio-Tech at Quasar Bio-Tech Inc., Attn: Quality/Recall Coordinator, 1431 Tallevast Road, Sarasota FL 34243. If you have any questions, contact the Quality/Recall Coordinator at 941-306-5812, Monday-Friday from 9:00 am to 5:00 pm Eastern Standard time.

Device

Quasar MD
  • Modèle / numéro de série
    Quasar MD- Model QMD-101 UPC Code 837654072196, Batch # 11652, 11727, 2441, 11870, 11884, 11955, 11969, 12005, 12006, 12029, 12057, 13008, 13193, 13199, 13221, 13242, 13271, 13288, 13325, 13514, 13521.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, FL, GA, HI, ID, IL, KS, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OR, TN, TX, UT, VA, and WA; and countries of: Aruba, Canada, Cayman Islands, China, Estonia, Ireland, Malaysia, New Zealand, Singapore, Sweden, Taiwan, and United Kingdom.
  • Description du dispositif
    Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" || The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
  • Manufacturer
    Quasar Bio-Tech, Inc. dba Silver Bay LLC

Manufacturer

Quasar Bio-Tech, Inc. dba Silver Bay LLC
  • Adresse du fabricant
    Quasar Bio-Tech, Inc. dba Silver Bay LLC, 1431 Tallevast Rd, Sarasota FL 34243-5035
  • Société-mère du fabricant (2017)
    Silver Bay Llc
  • Source
    USFDA