Firefly Medical, Inc. recalls IVEA Product Part Number 16100 Model 500A

Recall date

August 24, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3239-2017

FDA classification

Class II

Brand / firm

Firefly Medical, Inc.

Sold / distributed

United States, Australia, Belgium, Canada, China, Germany, Hong Kong, Indonesia, Israel, Netherlands, Singapore, UAE

Why it was recalled

The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

IVEA Product Part Number 16100 Model 500A