FDA Medical Device Recalls (openFDA)
First Source Inc: First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
- Recall number
- Z-2247-2024
- Recalling firm
- First Source Inc
- Product
- First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
- Status
- Open, Classified
- Initiated
- 2024-05-09
- Posted
- 2024-07-01
- Terminated
- not on file
- 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 (option 2) from 9:00 AM to 5:00 PM EST from Monday through Friday.
- 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.
- Lot, serial or model codes
- Model No. Pending; UDI-DI: G221500MC0740; Serial No. 4001, 4002, 4003, 4004, 4005, 4006, 4007, 4008, 4009, 4010, 4011, 4012, 4013, 4014, 4015, 4016, 4017, 4018, 4019, 4020, 4021, 4022, 4023, 4024, 4025, 4026, 4027, 4028, 4029, 4030, 4031, 4032, 4033, 4034, 4035, 4036, 4037, 4038, 4039, 4040, 4041, 4042, 4043, 4044, 4045, 4046, 4047, 4048, 4049, 4050, 4051, 4052, 4053, 4054, 4055, 4056, 4057, 4058, 4059, 4060.
- 510(k) numbers
- ["K221081"]
- PMA numbers
- not on file
- Product code
- IZL
- Firm FEI
- 3004063527
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28