FDA Recalls Robotic Hand Accessories Due to Pinch Hazard
Interactive Motion Technologies is recalling eight robotic hand accessories for the InMotion Arm rehabilitation robot due to a potential pinch hazard if protective covers are removed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (pinch hazard) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for eight robotic hand accessories used with the InMotion Arm rehabilitation robot. The recall was initiated by the manufacturer, Interactive Motion Technologies, Inc.
The recall is due to a potential pinch hazard. The source text indicates that an unsupervised patient could potentially misuse the device by removing or rotating a protective cover, which would expose the pinch hazard. The affected units are identified by serial numbers H006, H007, H019, H020, H021, H022, H023, and H024. Note that serial numbers may be written with an additional leading 0 (e.g., H0024 instead of H024).
The eight affected units were distributed worldwide, including to the United States (Texas and Tennessee) and to China, Brazil, Hong Kong, Austria, and South Korea. Consumers and healthcare providers should stop using the affected accessories and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- Robotic hand accessory to InMotion Arm, rehabilitation robot.
- Manufacturer
- Interactive Motion Technologies, Inc.
- Hazard
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Serial Numbers: H006
- H007
- H019
- H020
- H021
- H022
- H023
Distribution
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