FDA-Device2023-05-24Class II
Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
Philips North America Llc
Hazard
Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.
Sold states
Worldwide - US Nationwide distribution including in the states of States: AZ, IN, MA, MD, MN, NY, OH, PA, and TX. The countries of Australia, Austria, China, Czech Republic, Denmark, France, Germany, Israel, Japan, Malaysia, Netherlands, Norway, Palestine, Panama, South Korea, Spain, Switzerland, Thailand, United Kingdom.
Affected count
92 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1584-2023Don't want to check this manually?
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