FUJIFILM Healthcare Americas Corporation is recalling 18 units of the FDR Visionary Suite, a digital radiography system used for medical imaging. The recall was initiated because the bolts on the CH-200 tube can rupture due to fatigue failure, which may cause the heavy tube support to fall unexpectedly. This system is used for routine X-rays of the chest, abdomen, spine, and extremities; however, a falling tube support could strike a patient or staff member during an exam.
The structural bolts can fail over time due to fatigue, leading to the sudden collapse of the tube support mechanism. If the support falls while a patient is positioned under the device, it could result in serious impact injuries or blunt force trauma.
Manufacturer initiated recall via letter notification.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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