TradepilotUSA
TradepilotUSA Recalls

TradePilot Recalls

Official product recall notices and clearly labeled enforcement reference records.

Reference notice · device

CooperSurgical, Inc. — INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715.

Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.

Trumbull, CT, US · Updated 9/18/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Philips North America Llc — Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Du

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Cambridge, MA, US · Updated 9/18/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

CooperSurgical, Inc. — INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715.

Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.

Trumbull, CT, US · Updated 9/18/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Philips North America Llc — Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Cambridge, MA, US · Updated 9/18/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Philips North America Llc — Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Cambridge, MA, US · Updated 9/18/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Philips North America Llc — Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 7812

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Cambridge, MA, US · Updated 9/18/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Philips North America Llc — Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Cambridge, MA, US · Updated 9/18/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Philips North America Llc — Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5. 782107(X), 6. 782119(X), 7. 782136(X), 8. 782158(X);

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Cambridge, MA, US · Updated 9/18/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Philips North America Llc — Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion),

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Cambridge, MA, US · Updated 9/18/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Philips North America Llc — SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Cambridge, MA, US · Updated 9/18/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference
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