Events

Recall of Device Recall InMotion Hand a.k.a. InMotion 5.0

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Interactive Motion Technologies, 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
    72326
  • Event Risk Class
    Class 2
  • Event Number
    Z-0199-2016
  • Event Initiated Date
    2012-05-05
  • Event Date Posted
    2015-11-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141071
  • 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
    System, isokinetic testing and evaluation - Product Code IKK
  • Reason
    Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard.
  • Action
    Interactive Motion Technology ( IMT) sent an Important Patient Safety Information letter dated March 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Summary of Actions to be taken For Hand Robot Cover B, firm recommends continued vigilance for both Adult and Pediatric Patients while in contact with this group of devices. For Hand Robot Covers A or C, at clinician discretion based on expected patient population, firm recommends continued use when appropriate of the IMT supplied Hypertonia Spring Assembly, or if not appropriate, insertion of the IMT Zero Force Spring Assembly. IMT will make this kit available for each Hand Robot upon request, or insert the Assembly when the Hand Robot is shipped to IMT using the special shipping container. If you have any questions, please contact your local IMT Representative or IMT Technical Services at support@interactive-motion.com.

Device

Device Recall InMotion Hand a.k.a. InMotion 5.0
  • Model / Serial
    Serial Numbers: H006, H007, H019, H020, H021, H022, H023, H024. Note: serial numbers may be written with an additional leading 0 (e.g. H0024 instead of H024)
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of : Texas and Tennessee., and to the countries of : China, Brazil, Hong Kong, Austria and South Korea.
  • Product Description
    Robotic hand accessory to InMotion Arm, rehabilitation robot.
  • Manufacturer
    Interactive Motion Technologies, Inc.

Manufacturer

Interactive Motion Technologies, Inc.
  • Manufacturer Address
    Interactive Motion Technologies, Inc., 80 Coolidge Hill Rd, Watertown MA 02472-5003
  • Manufacturer Parent Company (2017)
    Bionik Laboratories Inc
  • Source
    USFDA