Moderate riskFDA DeviceClass II

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

  1. If you operate a Philips Spectral CT 7500 with serial number 1005, 1007, or 1008, contact Philips immediately
  2. Do not operate the affected scanner until fasteners are inspected and retorqued to specification by a qualified technician
  3. 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.

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