Medical Device Recall: Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Philips North America Llc · April 1, 2025
Reason for Recall
Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
Distribution
Worldwide distribution: US (Nationwide); and OUS (Foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Czech Republic, Estonia, France, Germany, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Lebanon, Libya, Luxembourg, Mauritius, Mexico, Monaco, Morocco, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Puerto Rico, R¿union, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, T¿rkiye, Turkmenistan, United Kingdom, UAE & Yemen.
States Affected
NATIONWIDE
Quantity Affected
630 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1660-2025
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.