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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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
See all →- HighPortable X-Ray Cart Positioning Arm Bolt May Come Loose and Fall
FDA (Devices) · 2024-07-10
Same hazard · loose bolt
See all →- High
- High
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NHTSA · 2022-09-29
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