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Recall

Class II — First Source Inc

Recalling firmFirst Source Inc
Registered facilityFIRST SOURCE INC. (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonPotential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
ProductFirst Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
Quantity680 units
DistributionWorldwide - 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.
Initiated2024-05-09
Classified2024-07-01
Recall numberZ-2246-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — First Source Inc (Z-2246-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94744/

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