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U.S. Department of Health and Human Services

Class 2 Device Recall InMotion Hand a.k.a. InMotion 5.0

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  Class 2 Device Recall InMotion Hand a.k.a. InMotion 5.0 see related information
Date Initiated by Firm May 05, 2012
Date Posted November 02, 2015
Recall Status1 Terminated 3 on July 13, 2017
Recall Number Z-0199-2016
Recall Event ID 72326
Product Classification System, isokinetic testing and evaluation - Product Code IKK
Product Robotic hand accessory to InMotion Arm, rehabilitation robot.
Code Information 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)
Recalling Firm/
Manufacturer		 Interactive Motion Technologies, Inc.
80 Coolidge Hill Rd
Watertown MA 02472-5003
Manufacturer Reason
for Recall		 Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard.
FDA Determined
Cause 2		 Component design/selection
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.
Quantity in Commerce 8
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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