Medical device recalls Moderate risk

First Source Inc recalls First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.

Recall date
May 9, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2246-2024
FDA classification
Class II
Brand / firm
First Source Inc
Sold / distributed
Worldwide - US Nationwide distribution in the states of AR, CA, FL, GA, IL, IN, LA, MA, MD, MI, MO, MS, NC, NY, OK, PA, TN, TX, & VA. The countries of Korea & Serbia.

Why it was recalled

Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.

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

What was recalled

First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.

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