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Other Medical Devices

🏥 Medical Devices 15,203 recalls

Intera 1.5T Master/Nova, Model Number: 781106;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Class I - Dangerous

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Mar 24, 2025 Other Medical Devices Nationwide View Details →

SmartPath to dStream for 3.0T, Model Number: 782145;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Class I - Dangerous

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Mar 24, 2025 Other Medical Devices Nationwide View Details →

Intera 1.5T Explorer/Nova Dual, Model Number: 781108;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Class I - Dangerous

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Mar 24, 2025 Other Medical Devices Nationwide View Details →

SmartPath to dStream for 1.5T, Model Number: 782146;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Class I - Dangerous

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Mar 24, 2025 Other Medical Devices Nationwide View Details →

Intera 1.0T Omni/Stellar, Model Number: 781102;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Class I - Dangerous

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Mar 24, 2025 Other Medical Devices Nationwide View Details →

Enterprise 1.5T, Model Number: 781145;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Class I - Dangerous

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Mar 24, 2025 Other Medical Devices Nationwide View Details →

The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs.

Apr 9, 2025 Other Medical Devices View Details →

Intera 1.5T Omni/Stellar, Model Number: 781104;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Class I - Dangerous

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Mar 24, 2025 Other Medical Devices Nationwide View Details →

Intera 0.5T Standard, Model Number: 781101;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Class I - Dangerous

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Mar 24, 2025 Other Medical Devices Nationwide View Details →

Intera 3.0T Quasar Dual, Model Number: 781150;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Class I - Dangerous

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Mar 24, 2025 Other Medical Devices Nationwide View Details →

Intera 1.5T Power/Pulsar, Model Number: 781105;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Class I - Dangerous

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Mar 24, 2025 Other Medical Devices Nationwide View Details →

Intera 1.5T R11, Model Number: 781170;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Class I - Dangerous

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Mar 24, 2025 Other Medical Devices Nationwide View Details →

Intera 1.5T, Model Numbers: 781195 and 781295;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Class I - Dangerous

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Mar 24, 2025 Other Medical Devices Nationwide View Details →

Intera 1.0T Power/Pulsar, Model Number: 781103;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Class I - Dangerous

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

Mar 24, 2025 Other Medical Devices Nationwide View Details →