CLASS II ONGOING Device recall · Reported 30 Apr 2025 · FDA Enforcement Report
Philips Brilliance CT Big Bore recalled by Philips North America
Philips North America is recalling Philips Brilliance CT Big Bore, distributed nationwide in the US. The recall was initiated on 1 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1660-2025
- FDA event ID
- 96667
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Apr 2025
- FDA classified
- 23 Apr 2025
- Reported
- 30 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Imaging Equipment
Timeline
| 1 Apr 2025 | Recall initiated by company | |
| 23 Apr 2025 | Classified by FDA | +22 days |
| 30 Apr 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Where it was distributed
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.
Questions about this recall
Is Philips Brilliance CT Big Bore recalled?
Yes. Philips North America recalled Philips Brilliance CT Big Bore on 1 Apr 2025. The recall is Class II and its status is Ongoing. Recall number Z-1660-2025.
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.
Which lots are affected?
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, 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Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips North America
All 531Other Imaging Equipment recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ultrasound Breast Pack recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled | Canon Medical System, USA | Other | Nationwide |
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederland B.v | Lead & Heavy Metals |