Class II

Medical Device Recall: The Oncology Essentials Package of the Spectral CT imaging system.

Philips North America Llc · March 29, 2024

Reason for Recall

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.

Distribution

Worldwide distribution - US Nationwide in the states of AZ, HI, MN, VT, WV and the countries of China, Macao, New Zealand, Portugal, Switzerland.

States Affected

NATIONWIDE

Quantity Affected

12 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1756-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Philips North America Llc Medical Device Recall: The Oncology Essentials Package of the Spectral CT imaging system. | SafeCheck