Philips North America Llc: The Oncology Essentials Package of the Spectral CT imaging system.

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.

Details from the source

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. Quantity: 12 units Lot/code info: Model No. 728333; UDI: (01)00884838101111(21); Serial No. 10069, 10084, 10169, 10137, 10163, 10196, 10181, 10199, 10210, 10206, 10202, 10139.

UPC codes

00884838101111

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.