Recall Z-2247-2024 ยท IZL System, X-Ray, Mobile
First Source Inc
First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
| Date | Jul 1, 2024 (initiated May 9, 2024) |
| Status | Open, Classified |
| Reason | Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient. |
| Root cause | Device Design |
| 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 support@fsimed.com or by phone at 1-800-349-5980 ( |
| Quantity | 137 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221081 | iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System First Source, Inc., Jun 13, 2022 |