Events

Recall of Device Recall RS4i Sequential Stimulator;

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by International Rehabilitative Sciences, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55655
  • Event Risk Class
    Class 2
  • Event Number
    Z-0323-2011
  • Event Initiated Date
    2008-06-11
  • Event Date Posted
    2010-11-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91463
  • Notes / Alerts
    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.
  • Extra notes in the data
    Stimulator, muscle, powered - Product Code IPF
  • Reason
    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;
  • Model / Serial
    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.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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.