FDA-Device2024-05-08Class II
The Oncology Essentials Package of the Spectral CT imaging system.
Philips North America Llc
Hazard
Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and subsequent incorrect treatment.
Sold states
Worldwide distribution - US Nationwide in the states of AZ, HI, MN, VT, WV and the countries of China, Macao, New Zealand, Portugal, Switzerland.
Affected count
12 units
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
The Oncology Essentials Package of the Spectral CT imaging system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1756-2024Don't want to check this manually?
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