PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
102 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-05-21FDA-DeviceClass IIIntera 1.5T Omni/Stellar, Model Number: 781104;
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.
- 2025-05-21FDA-DeviceClass IIIntera 1.5T Master/Nova, Model Number: 781106;
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.
- 2025-05-21FDA-DeviceClass IIIntera 1.5T Explorer/Nova Dual, Model Number: 781108;
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.
- 2025-05-21FDA-DeviceClass IIIntera 1.5T, Model Numbers: 781195 and 781295;
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.
- 2025-05-21FDA-DeviceClass IIIntera 1.0T Power/Pulsar, Model Number: 781103;
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.
- 2025-05-21FDA-DeviceClass IIIntera 1.0T Omni/Stellar, Model Number: 781102;
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.
- 2025-05-21FDA-DeviceClass IIIntera 0.5T Standard, Model Number: 781101;
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.
- 2025-05-21FDA-DeviceClass IIEnterprise 1.5T, Model Number: 781145;
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.
- 2025-05-14FDA-DeviceClass IIIntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
- 2025-04-30FDA-DeviceClass IIZenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
- 2025-03-19FDA-DeviceClass IISpectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
- 2025-03-12FDA-DeviceClass IIPhilips IntelliSpace Cardiovascular software, Model 830089.
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Get notified about new PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls
Free weekly digest. We email when a new federal recall affects PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or anything else in your household.
Get the Sunday Brief