Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Reported: April 30, 2025 Initiated: April 1, 2025 #Z-1660-2025
Product Description
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Reason for Recall
Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
Details
- Recalling Firm
- Philips North America Llc
- Units Affected
- 630 units
- 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.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.. Recalled by Philips North America Llc. Units affected: 630 units.
Why was this product recalled? ▼
Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 30, 2025. Severity: Moderate. Recall number: Z-1660-2025.
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