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Recall Observatory FDA recall evidence

Device product

Robotic hand accessory to InMotion Arm, rehabilitation robot.

Z-0199-2016

May 05, 2012

Class II

Product summary

Firm
Interactive Motion Technologies, Inc.
Event
Event 72326
Status
Terminated
Classification
Class II
Quantity
8
Official record key
device-enforcement:Z-0199-2016

Official wording

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

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)

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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