Z-2247-2024Class II

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

Name: Z-2247-2024 First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer
Creator: First Source Inc
Published: 2024-05-09
License: https://open.fda.gov/license/

First Source Inc / initiated 2024-05-09 / Open, Classified / root cause: design

FDA source

First Source Inc began a recall of First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer on 2024-05-09. FDA classified it as Class II and gives the reason as "Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2247-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-09
Posted: 2024-07-01
Recalling firm: First Source Inc
Product: First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
Product code: IZL System, X-Ray, Mobile
Reason for recall: Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees 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 [email protected] 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 commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2247-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2246-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-01
Z-2247-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-01

Product code IZL

K221081Class IIiQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray SystemFirst Source, Inc. / cleared 2022-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)