Device product
Robotic hand accessory to InMotion Arm, rehabilitation robot.
Z-0199-2016
Product summary
- 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
Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard.