Product Wiki · Recalls · U.S. FDA — Device Enforcement

Robotic hand accessory to InMotion Arm, rehabilitation robot. — recall Z-0199-2016

U.S. FDA — Device Enforcement · United States · 2012-05-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0199-2016
Date of alert
2012-05-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Interactive Motion Technologies, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
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.
Reported risk: Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.