The Recall Desk
HighFDA (Devices)·Z-2247-2024·Announced 2024-07-10

X-ray cart positioning arm bolt may loosen and fall onto patient

A bolt securing the positioning arm on First Source iQ Flex M X-ray carts may come loose and fall onto patients. The recall involves 137 units distributed across the US, Korea, and Serbia.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with a potential hazard (loose bolt that could strike a patient), but with no reported illnesses, injuries, or hospitalizations. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3.

Plain-English summary

First Source Inc is recalling the First Source iQ Flex M, a portable cart and platform designed to support X-ray systems and laptop computers. A total of 137 units are affected.

The recall addresses a potential safety issue: the bolt that secures the positioning arm to the gas spring may come loose and fall. This could result in the bolt striking a patient.

The affected units, identified by serial numbers 4001 through 4060, have been distributed globally. In the United States, the devices are located in Arkansas, California, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, Texas, and Virginia. Units have also been distributed to Korea and Serbia.

The recalled product

Product
First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.
Manufacturer
First Source Inc
Category
Medical Device — X-ray Equipment
Hazard
Affected units
137

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically:

Part of a larger recall action

This product is one of 2 recalled by First Source Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · First Source Inc

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Same hazard · loose bolt

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