FDAApril 15, 2024device
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
What to do
FDA enforcement status: Ongoing
Brands named
philips north americaphilipsphilips north
UPCs
00884838085015500211500216
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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