First Source Inc: First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.

Hazard

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

Details from the source

Reason for recall: Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient. 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. Quantity: 137 units Lot/code info: 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.