FDA-Device2024-07-10Class II

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

First Source Inc
Hazard

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

Sold states
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.
Affected count
680 units
Manufactured in
3495 Winton Pl Bldg E, Ste 1, Rochester, NY, United States
Products
First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2246-2024

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