Philips North America Llc: When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

Agency Publication Date: August 18, 2021

Affected Products

Product: 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades

S/N UDI: 87013 (01)00884838059474(21)87013 87008 (01)00884838059474(21)87008 87011 (01)00884838059474(21)87011 Software Version 4.1.10 SynchRight Option

Product: Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray system

Model: 728321 S/N UDI: 40012 (01)00884838059498(21)40012 Model: 728332 40004 (01)00884838059504(21)40004 Software Version: 4.1.10 SynchRight Option

Product: 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system

Serial Number: 300099 300106 300143 Software Version 4.1.10 SynchRight Option

Product: 728332 IQon Spectral CT-Computed Tomography X-ray system

Serial Number/UDI: 60001 (01)00884838059542(21)60001, 60005 (01)00884838059542(21)60005, 60015 (01)00884838059542(21)60015, 60017 (01)00884838059542(21)60017, 860026 (01)00884838059542(21)860026, 860035 (01)00884838059542(21)860035, 860053 (01)00884838059542(21)860053 860074 (01)00884838059542(21)860074, 860108 (01)00884838059542(21)860108, 860109 (01)00884838059542(21)860109. Software Version 4.7.7 SynchRight Option

Product: 728333 Spectral CT 7500 -Computed Tomography X-ray system

Serial Number/UDI: 10019 (01)00884838101111(21)10019 Software Version 5.0.0 SynchRight Option

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88336

Status: Resolved

Manufacturer: Philips North America Llc

Manufactured In: United States

Units Affected: 4 products (3 units; 2 units; 3 units; 1 unit)

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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

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