Company: Philips North America Llc
Date of Enforcement Report: 6/26/2025
Class: II

PRODUCT

Spectral CT. Computed tomography X-ray system.

Recall Number:

Z-2034-2025

REASON:

Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.

RECALLING FIRM/MANUFACTURER:

Philips North America Llc

VOLUME:

370 units

DISTRIBUTION:

Domestic: AZ, CA, CO, FL, GA, HI, IN, KY, MA, MD, MN, NY, OH, OR, PA, TX, VT, WA, WV; Foreign: Australia, Austria, Belgium, China, Czech Republic, Denmark, Ecuador, France, Germany, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Macao, Malaysia, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam