Device product
First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
Z-2247-2024
Product summary
- Firm
- First Source Inc
- Event
- Event 94744
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 137 units
- Official record key
device-enforcement:Z-2247-2024
Official wording
Reason: Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
Code information: 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.
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.
Derived failure modes
-
Unknown
Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.