First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop compu...
FDA Recall #Z-2247-2024 — Class II — May 9, 2024
Product Description
First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
Reason for Recall
Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
Recalling Firm
First Source Inc — Rochester, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product 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.
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated