First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
FDA Recall Z-2247-2024 · Posted 2024-07-01
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Recalling FirmFirst Source Inc
Recall StatusOpen, Classified
Product CodeIZL
Date Initiated2024-05-09
Product Quantity137 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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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