Recall Z-0199-2016 ยท IKK System, Isokinetic Testing And Evaluation
Interactive Motion Technologies, Inc.
Robotic hand accessory to InMotion Arm, rehabilitation robot.
| Date | Nov 2, 2015 (initiated May 5, 2012) |
| Status | Terminated |
| Reason | Unsupervised patient could potentially mis-use the device and remove or rotate a protective cover and expose a potential pinch hazard. |
| Root cause | Component design/selection |
| 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 n |
| Quantity | 8 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.