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Terminated

Robotic hand accessory to InMotion Arm, rehabilitation robot.

FDA Recall Z-0199-2016 · Posted 2015-11-02

Recall StatusTerminated
Product CodeIKK
Date Initiated2012-05-05
Date Terminated2017-07-13
Product Quantity8

Reason for Recall

Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard.

Firm 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 [email protected].

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - US Distribution to the states of : Texas and Tennessee., and to the countries of : China, Brazil, Hong Kong, Austria and South Korea.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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