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Philips North America Llc recalls Incisive CT Computed Tomography X-ray System Model: 728143
Recalled March 24, 2021 · FDA recall Z-1265-2021 · Philips North America
Hazard
Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the tilt limit angle +31degrees · FDA Class II
Units
105 units (1 US and 104 OUS)
Sold at
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Description
Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the tilt limit angle +31degrees
Product
Incisive CT Computed Tomography X-ray System Model: 728143
Manufacturer(s)
Philips North America Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →