FDA recall Z-1756-2024

Philips North America Llc · Class II · device

Product

The Oncology Essentials Package of the Spectral CT imaging system.

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.

Key facts

Status
Ongoing
Initiation date
2024-03-29
Report date
2024-05-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1756-2024