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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Philips North America, LLC: The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.

Agency Publication Date: May 6, 2020
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Affected Products

Product: Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848

Serial #s 100193, 100408, 100457, 100783, 100356, 100113, 100380, 100318, 100848, 100112, 100742, 100447, 100685, 100375, 100449, 100659, 100158, 100398 Additional serial number as of 5/22/20: 100117

Product: Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311

Serial # 200044 Additional unit as off 5/22/20: 200026

Product: Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067

Serial #s 860067, 860023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85513
Status: Resolved
Manufacturer: Philips North America, LLC
Manufactured In: United States
Units Affected: 3 products (19; 2; 2)
Agency Last Updated: June 23, 2020

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.