Philips North America Llc: IQon Spectral CT; Product Code (REF): 728332;

Company / brand

Philips North America Llc

Product

IQon Spectral CT; Product Code (REF): 728332;

Reason / 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.

Classification

Class II

Status

Ongoing

Distribution / sold at

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.

Recall initiated

2026-01-07

Code info

Product Code (REF): 728332; UDI-DI: 00884838059542; Serial Numbers: 60128, 60141, 60151, 60161, 60171, 60181, 60129, 60142, 60152, 60162, 60172, 60182, 60130, 60143, 60153, 60163, 60173, 60132, 60144, 60154, 60164, 60174, 60133, 60145, 60155, 60165, 60175, 60134, 60146, 60156, 60166, 60176, 60136, 60147, 60157, 60167, 60177, 60137, 60148, 60158, 60168, 60178, 60138, 60149, 60159, 60169, 60179, 60139, 60150, 60160, 60170, 60180,

Product quantity

52 units

Voluntary mandated

Voluntary: Firm initiated

City

Cambridge

State

MA

Country

United States

Event id

98248

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