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Open, Classified

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

Recall StatusOpen, Classified
Product CodeJAK
Date Initiated2025-04-01
Product Quantity630 units

Reason for Recall

Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

Firm Action

An "URGENT Medical Device Correction" Notice dated 4/1/25 was mailed to consignees. The notice instructs consignees on how to identify if their unit is affected by this recall. Consignees are instructed to continue use of affected devices by following the recommended actions outlined in the notice and Appendix A. Consignees are asked to return the completed URGENT Medical Device Correction Response Form within 30 days of notification of this recall event via email: [email protected]. The recall notification is to be circulated among users and retained near affected devices until the update is installed. Philips will be contacting consignees to schedule a Field Service Engineer to visit affected sites and install the update (FCO72800825). Consignees with any questions are to call the Customer Care Solutions Center at 1-800-722-9377.

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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