FDA Medical devices recall ·
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430… recall
- Recall number
- Z-1660-2025
- Date
- (initiated April 1, 2025)
- Company / brand
- Philips North America Llc
222 Jacobs St, Cambridge, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 630 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Why was it recalled?
Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. 728242, 728243, 728244; UDI: (01)00884838098725(21)7014, (01)00884838098725(21)7032, (01)00884838059450(21)7056, (01)00884838098725(21)7060, (01)00884838098725(21)7062, (01)00884838098725(21)7064, (01)00884838098725(21)7072, (01)00884838098725(21)7087, (01)00884838059450(21)7096, (01)00884838059450(21)7123, (01)00884838059450(21)7124, (01)00884838098725(21)7128, (01)00884838098725(21)7135, (01)00884838098725(21)7154, (01)00884838098725(21)7163, (01)00884838098725(21)7179, (01)00884838098725(21)7191, (01)00884838098725(21)7220, (01)00884838098725(21)7221, (01)00884838098725(21)7229, (01)00884838059450(21)7240, (01)00884838098725(21)7245, (01)00884838098725(21)7246, (01)00884838098725(21)7247, (01)00884838098725(21)7254, (01)00884838098725(21)7256, (01)00884838098725(21)7282, (01)00884838098725(21)7283, (01)00884838098725(21)7292, (01)00884838098725(21)7297, (01)00884838098725(21)7304, (01)00884838098725(21)7306, (01)00884838098725(21)7309, (01)00884838098725(21)7311, (01)00884838098725(21)7331, (01)00884838098725(21)7332, (01)00884838059450(21)7333, (01)00845225003036(10)0302624730(21)7336, (01)00845225003036(10)0302624730(21)7341, (01)00845225003036(10)0302624730(21)7345, (01)00845225003036(10)0302624730(21)7348, (01)00845225003036(10)0302624730(21)7353, (01)00884838059450(21)7355, (01)00884838059450(21)7362, (01)00845225003036(10)0302624730(21)7364, (01)00845225003036(10)0302624730(21)7367, (01)00845225003036(10)0302624730(21)7373, (01)00884838098725(21)7396, (01)0
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: Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1660-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.