FDA (Devices) recall action 94744
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
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.
First Source Inc is recalling the First Source Vision M portable X-ray cart because the bolt securing the positioning arm to the gas spring may come loose and fall onto a patient.