Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
FDA Recall Z-1660-2025 · Posted 2025-04-23
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Reason for Recall
Firm Action
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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