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Philips North America Llc recalls The Oncology Essentials Package of the Spectral CT imaging system.
Recalled May 8, 2024 · FDA recall Z-1756-2024 · Philips North America
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. · FDA Class II
Units
12 units
Sold at
Worldwide distribution - US Nationwide in the states of AZ, HI, MN, VT, WV and the countries of China, Macao, New Zealand, Portugal, Switzerland.
Description
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.
Product
The Oncology Essentials Package of the Spectral CT imaging system.
Manufacturer(s)
Philips North America Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →