Philips Spectral CT 7500 on Rails recalled for potentially loose rotor fasteners
Philips has recalled three Spectral CT 7500 CT scanner systems because fasteners that secure the rotor inside the gantry may not have been tightened to the correct specification. If multiple fasteners are loose, rotor parts could become unsecured or displaced during operation. No parts have been expelled or injuries reported so far.
From the FDA notice · Read the official notice ↗ · All Philips recalls
What to do
- If you operate a Philips Spectral CT 7500 with serial number 1005, 1007, or 1008, contact Philips immediately
- Do not operate the affected scanner until fasteners are inspected and retorqued to specification by a qualified technician
- Verify that all 32 rotor fasteners meet torque specifications before resuming patient scans
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Spectral CT 7500 on Rails; Product Code (REF): 728334;
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 4 products — see all of them.
Details
- Units affected
- 3 units
- Illnesses reported
- None reported
- Manufactured in
- 222 Jacobs St, N/A, Cambridge, MA, United States
- Classification
- Class II
- Recall number
- Z-1318-2026
In the FDA's words
- Description
- Spectral CT 7500 on Rails; Product Code (REF): 728334; As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled. Product Code (REF): 728334; UDI-DI: 00884838103627; Serial Numbers: 1005, 1007, 1008; Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lithuania, Macao, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, R¿union, Russian Fed., Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkmenistan, United Kingdom, Uzbekistan, Vietnam. Affected quantity: 3 units
- Hazard
- As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
4 products in this recall
Philips CT scanners recalled for loose rotor fastener risk
Philips is recalling four CT scanner models because one or more of the 32 fasteners that attach the rotor to the gantry bearing may not be tightened to specification. If several fasteners are loose, rotor parts could become unsecured or displaced, and in theory could be expelled. The company reports no injuries and no observed parts being expelled during gantry rotation.
The agency lists each product separately. Check every one you might have.
- Brilliance iCT; Product Code (REF): 728306;Z-1315-2026 · 47 units
- IQon Spectral CT; Product Code (REF): 728332;Z-1316-2026 · 52 units
- Spectral CT; Product Code (REF): 728333;Z-1317-2026 · 283 units
- Spectral CT 7500 on Rails; Product Code (REF): 728334; (this page)Z-1318-2026 · 3 units
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