Events

Recall of RT300-S (ADULT VERSION)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RESTORATIVE THERAPIES 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
    25149
  • Event Risk Class
    II
  • Event Initiated Date
    2010-05-13
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    As a result of a torus fracture experienced by a child while arm fes cycling restorative therapies is adding a statement of caution to the rt300 user guide that applies to children under 14 years old while arm cycling. the additional statement of caution provides directions to reduce the chance of wrist injury.

Device

RT300-S (ADULT VERSION)
  • Model / Serial
    Model Catalog: FA104581 (Lot serial: lot# 09141130); Model Catalog: FA100052 (Lot serial: lot# 007092039); Model Catalog: FA102011 (Lot serial: lot# 09141130); Model Catalog: FA100052 (Lot serial: lot# 09141130); Model Catalog: FA104581 (Lot serial: lot# 006454068); Model Catalog: FA102011 (Lot serial: lot# 006454068); Model Catalog: FA100052 (Lot serial: lot# 006454068); Model Catalog: FA104581 (Lot serial: lot# 007091009); Model Catalog: FA102011 (Lot serial: lot# 007091009); Model Catalog: FA100052 (Lot serial: lot# 007091009); Model Catalog: FA104581 (Lot serial: lot# 006473007); Model Catalog: FA102011 (Lot serial: lot# 006473007); Model Catalog: FA100052 (Lot serial: lot# 006473007); Model Catalog: FA104581 (Lot serial: 007222087); Model Catalog: FA102011 (Lot serial: 007222087); Model Catalog: FA100052 (Lot serial: 007222087); Model Catalog: FA104581 (Lot serial: lot# 08495125); Model Catalog: FA102011 (Lot serial: lot# 08495125); Model Catalog: FA100052 (Lot serial: lot# 08495125); Model Catalog: FA1
  • Product Description
    FES Leg/Arm Cycle Ergometer RT300
  • Manufacturer
    RESTORATIVE THERAPIES INC.

Manufacturer

RESTORATIVE THERAPIES INC.