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Open, Classified

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

FDA Recall Z-2246-2024 · Posted 2024-07-01

Recalling FirmFirst Source Inc
Recall StatusOpen, Classified
Product CodeIZL
Date Initiated2024-05-09
Product Quantity680 units

Reason for Recall

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

Firm Action

Consignees were emailed an URGENT: MEDICAL DEVICE RECALL notification, dated 5/29/24. The notice instructs consignees to follow the recommended preventive maintenance schedule and visually check the device before use to identify if the affected bolt is coming loose. The recalling firm is currently testing a spring clip which will keep the bolt from falling out and will send this part to customers at no charge once approved. Consignees are asked to return the provided response form. Consignees with any questions can contact the firm by email at [email protected] or by phone at 1-800-349-5980 (option 2) from 9:00 AM to 5:00 PM EST from Monday through Friday.

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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