Philips North America Llc is recalling 2,347 units of its Incisive CT and CT 5300 systems, including software versions 4.5, 5.0, and 5.1. The recall was issued because a component called the tube heat exchanger on the rotating scanner may not have its screws tightened correctly after being replaced. If these screws are loose, the heat exchanger can become detached while the machine is spinning, potentially crashing into and damaging other sensitive internal components of the CT system.
A detached heat exchanger can make physical contact with other internal parts during scanner rotation, which can damage the system and potentially lead to equipment failure or scan interruptions during a medical procedure.
Includes units with Software Versions 4.5, 5.0, 5.1.
Includes units with Software Versions 4.5, 5.0, 5.1.
Includes 6 units (Outside US only). Software Versions 4.5, 5.0, 5.1.
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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