Events

Rappel de Device Recall RS4i Sequential Stimulator;

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 International Rehabilitative Sciences, 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
    55655
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0323-2011
  • Date de mise en oeuvre de l'événement
    2008-06-11
  • Date de publication de l'événement
    2010-11-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91463
  • 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
    Stimulator, muscle, powered - Product Code IPF
  • Cause
    The charge current is leaking through two diodes, which are supposed to block the reverse current, when the device is warm during the main battery charge operation, it then causes the lithium battery to swell around two years of use and it causes the device to be inoperable.
  • Action
    Since June 11, 2008, RS Medical has taken the following actions when the device was sent back through a consumer complaint, or when the device was returned for routine maintenance, or through the rental service. The firm has upgraded the blocking diodes with higher temperature rated diodes, replaced the Lithium coin cell battery, and the software register bit has been changed to denote for subsequent automated testing that the diode upgrade/Lithium coin cell battery replacement has occurred. The firm reported that the device must be returned for the rechargeable NiMH battery replacement around two years of use, and the battery should not be replaced by patients. On 10/29/10, the firm began sending out URGENT NOTICE of VOLUNTARY RECALL letters to their customers. The firm will continue to send out the letters through 2011. The letter states the recall product as RS-4i Sequential Stimulator, Affected Serial Numbers 4i300000 to 4i467119. The customers are informed that "RS-4i Sequential Stimulators, only those within the affected serial number range indicated above, are susceptible to early expiration of the lithium coin cell battery that provides back-up power to the device memory when the stimulator is powered OFF. Customer experience indicates that the 3V lithium coin cell battery can be depleted as early as one third of its rated life. The RS-4i Stimulator will perform as intended until the lithium coin cell battery is fully depleted. When this happens, the Stimulator will turn OFF and fail to turn ON, even if it has been charged by battery charger connection to a standard electrical wall outlet". Customers are advised to make a schedule for a free Return and Repair of a RS-4i Sequential Stimulator and should call the Toll Free Service Line at 877-363-5753 (English) or 877-363-5754 (Spanish) from 6AM to 5PM (Pacific Time) Monday-Friday. If the customers have any other questions or to review additional information before scheduling a device

Device

Device Recall RS4i Sequential Stimulator;
  • Modèle / numéro de série
    Device is labeled as 4i and a unique sequential six-digit number. 4i is specific for RS 4i device and six-digit sequential numbering for device. Serial numbers 4i300000 to 4i467119.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    The device is labeled in part: " RS Medical RS-4i Stimulator". The device is sold in a kit that includes a carrying case, connector cables, pads (electrodes), battery charger, patient document, instructional DVD, return mail bag, and the operation manual. || This device is used with cables and electrodes that are placed on skin in the treatment area, and allow an electrical micro-current to relieve pain. The device requires a prescription from a physician. It is programmed by an RS medical employee (or Account Manager) to the physician's specific treatment plan for each patient. The patient is given instructions on how to utilize the device (proper electrode placement). Powered MUSCLE Stimulation indications for use including: 1) Relax muscle spasm. 2) Prevention or retardation of disuse atrophy. 3) Maintain or increase range of motion. 4) Increase local blood circulation. 5) Re-educate muscle. 6) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. INTERFERENTIAL Stimulation indications for use including: 1) Relieve acute pain. 2) Relieve and manage chronic pain.
  • Manufacturer
    International Rehabilitative Sciences, Inc.

Manufacturer

International Rehabilitative Sciences, Inc.