Events

Rappel de Device Recall Apollo Therapy Laser

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 Pivotal Health Solutions.

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
    70473
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1250-2015
  • Date de mise en oeuvre de l'événement
    2014-12-17
  • Date de publication de l'événement
    2015-03-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133854
  • 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
    Control units were equipped with an internal mounting kit that does not meet medical safety standards, and are conductive, increasing the risk of electric shock to the user and patient. these units were manufactured prior to pivotal health solutions acquisition of the apollo product line.
  • Action
    The firm, Pivotal Health Solutions, sent a letter dated December 17, 2014 on 12/17/2014 and an amended Pivotal "Urgent Medical Device Recall" letter dated February 9, 2015 to its consignees/customers. The letters described the product, problem and actions to be taken. The consignees/customers were instructed to stop using the unit and contact Pivotal Health Solution's at 1-800-743-7738 to arrange for return and repair asap; immediately examine your device inventory and quarantine any product subject to recall; if you have further distributed the product, identify your customers and notify them at once of this product recall, and complete and return the enclosed RETURN AUTHORIZATION FORM with the units to Pivotal Service Center, 1654 Mardon Drive, Dayton, OH 45432 and the DECLARATION OF CONTAMINATION STATUS form via Fax to: 605-882-8398. If you have any questions, contact Pivotal Health Solutions Service Repair Coordinator at 800-743-7738 or email Robin@PivotalHealthSolusitons.com.

Device

Device Recall Apollo Therapy Laser
  • Modèle / numéro de série
    DT-1102, 1105, 1106, 1109, 1110, 1112,1114, 1115, 1116, 1118,1119, 1120, 1121, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1134, 1135, 1136, 1137, 1138, 1139, 1302, 1303, 1304, 1309.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: AZ, AR, CA, GA, IL, IN, IA, KS, MI, MN, MO, NY, OH, OR, PA, UT and WA.
  • Description du dispositif
    Apollo (cold) Laser Desktop Control Units, Model AP2-DT. || The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and / or promoting relaxation of muscle.
  • Manufacturer
    Pivotal Health Solutions

Manufacturer

Pivotal Health Solutions
  • Adresse du fabricant
    Pivotal Health Solutions, 724 Oakwood Road, Watertown SD 57201-4133
  • Société-mère du fabricant (2017)
    Pivotal Health Solutions
  • Source
    USFDA