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Moderate riskFDA DeviceClass II

Philips Brilliance iCT CT scanner recalled for potentially loose rotor fasteners

Philips has recalled certain Brilliance iCT CT scanners because fasteners that secure the rotor inside the gantry may not be tightened to the correct specification. If multiple fasteners are loose, rotor parts could potentially become displaced or expelled during scanning. No injuries or incidents have been reported.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

  1. If your facility operates one of the affected serial numbers (87064–87221), contact Philips immediately
  2. Do not operate the scanner until Philips confirms your unit's fasteners are properly torqued
  3. Provide your equipment serial number when contacting Philips for inspection and correction
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Brilliance iCT; Product Code (REF): 728306;
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 4 products — see all of them.

Details

Units affected
47 units
Illnesses reported
None reported
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Classification
Class II
Recall number
Z-1315-2026

In the FDA's words

Description
Brilliance iCT; Product Code (REF): 728306; 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): 728306; UDI-DI: 00884838059474; Serial Numbers: 87064, 87120, 87121, 87122, 87125, 87126, 87127, 87128, 87129, 87130, 87135, 87143, 87148, 87152, 87153, 87157, 87160, 87162, 87167, 87173, 87174, 87176, 87181, 87197, 87198, 87199, 87200 , 87202, 87203, 87204, 87205, 87206, 87207, 87208, 87209, 87210, 87211, 87212, 87213 , 87214, 87215, 87216, 87217, 87218, 87219, 87220, 87221; 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: 47 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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