Z-0199-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 11, 2015
- Initiation Date
- May 5, 2012
- Termination Date
- July 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
Product Description
Robotic hand accessory to InMotion Arm, rehabilitation robot.
Reason for Recall
Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard.
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.
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)