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U.S. Department of Health and Human Services

Class 2 Device Recall First Source iQ Flex M

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 Class 2 Device Recall First Source iQ Flex Msee related information
Date Initiated by FirmMay 09, 2024
Date PostedJuly 01, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2247-2024
Recall Event ID 94744
510(K)NumberK221081 
Product Classification System, x-ray, mobile - Product Code IZL
ProductFirst Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
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.
FEI Number 3004063527
Recalling Firm/
Manufacturer		 First Source Inc
3495 Winton Pl Bldg E
Ste 1
Rochester NY 14623-2824
For Additional Information ContactCustomer Service
585-272-1690
Manufacturer Reason
for Recall		Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
FDA Determined
Cause 2		Device Design
ActionConsignees 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 in Commerce137 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IZL
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