FDA Recalls Robotic Hand Accessories Due to Pinch Hazard

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.

Category

Medical Device — Rehabilitation Robot

Hazard

• pinch-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.

Distribution

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