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 — MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);

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

Reference notice · device

Abiomed, Inc. — Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Danvers, MA, US · Updated 9/16/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Abiomed, Inc. — Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Conn

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Danvers, MA, US · Updated 9/16/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Abiomed, Inc. — Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Danvers, MA, US · Updated 9/16/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Reference notice · device

Straumann USA LLC — GM Helix Implant, REF: 109.984;

There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.

Andover, MA, US · Updated 9/15/2026, 12:00:00 AM UTC

Source: FDA — device enforcement reference

Massachusetts — TradePilot Recalls