FDA Medical Device Recalls (openFDA)
Interactive Motion Technologies, Inc.: Robotic hand accessory to InMotion Arm, rehabilitation robot.
- Recall number
- Z-0199-2016
- Recalling firm
- Interactive Motion Technologies, Inc.
- Product
- Robotic hand accessory to InMotion Arm, rehabilitation robot.
- Status
- Terminated
- Initiated
- 2012-05-05
- Posted
- 2015-11-02
- Terminated
- 2017-07-13
- 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 not appropriate, insertion of the IMT Zero Force Spring Assembly. IMT will make this kit available for each Hand Robot upon request, or insert the Assembly when the Hand Robot is shipped to IMT using the special shipping container. If you have any questions, please contact your local IMT Representative or IMT Technical Services at support@interactive-motion.com.
- 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.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IKK
- Firm FEI
- 3002758968
- Firm city
- Watertown
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28