Severity
Moderate
FDA Devices recall · Reported July 10, 2024
Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
First Source Inc recalled First Source Vision M. Portable cart and platform that supports an X-ray system and lapto… - a moderate-severity action.
First Source Vision M. Portable cart and platform that supports an X-ray system and lapto… was recalled by First Source Inc in July 10, 2024. Reason: Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.. Check the official notice for the remedy. Verify recall #Z-2246-2024 with the FDA Devices before acting.
The recall
First Source Inc issued this moderate-severity FDA Devices recall-Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient..
Sourced from official FDA Devices enforcement records. Verify recall #Z-2246-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2246-2024) was formally reported on July 10, 2024, with the manufacturer initiating the action on May 9, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. First Source Inc is listed as the recalling firm, operating out of Rochester, NY. Federal records list the affected scope as 680 units.
The documented reason for this recall is: Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
680 units
Related Recalls
6
3 from same agency
First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2246-2024 |
| Date reported | July 10, 2024 |
| Date initiated | May 9, 2024 |
| Recalling firm | First Source Inc |
| Firm location | Rochester, NY |
| Affected scope | 680 units |
| Distribution | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 10, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.