First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
Summary
The FDA issued a Class II for First Source iQ Flex M. Portable cart and platform that supports an X-ray system by First Source Inc. Reason: Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient..
Details
Source
Device Recall
External ID
Z-2247-2024
Action Date
2024-07-10
Status
Ongoing
Category
device
Product Description
First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
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.
Quantity Affected: 137 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-09
Company
Rochester, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
First Source Inc has 4 FDA actions in our database, including 2 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (First Source Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does First Source Inc have FDA actions?
First Source Inc has 4 FDA actions in our database, including 2 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2247-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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