PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
127 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.
- 2025-08-06FDA-DeviceClass IIPhilips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper FD20 OR Table, Model Number: 722035. 7. Allura Xper FD20/20, Model Number: 722038 8. Allura Xper FD20/20 OR Table, Model Number: 722039. 9. Allura Xper FD20/15, Model N
Potential for temporary loss of imaging (X-ray) functionality due to software issue.
- 2025-07-30FDA-DeviceClass IIAzurion 7 M20. Fluoroscopic X-Ray System.
Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
- 2025-06-18FDA-DeviceClass IIAzurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: All software versions;
A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).
- 2025-05-21FDA-DeviceClass IISmartPath to dStream for 3.0T, Model Number: 782145;
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 IISmartPath to dStream for 1.5T, Model Number: 782146;
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 CV, Model Number: 781107;
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 3.0T Quasar Dual, Model Number: 781150;
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 R11, Model Number: 781170;
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 Power/Pulsar, Model Number: 781105;
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 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.
- 2025-02-26FDA-DeviceClass ICardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DeviceClass IAzurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DeviceClass IAzurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DeviceClass IAzurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DeviceClass IAzurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DeviceClass IAzurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DeviceClass IAzurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DeviceClass IAzurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
Possibility of the patient falling from the table related to the mattress used on the patient table.
- 2025-02-26FDA-DeviceClass IAzurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
Possibility of the patient falling from the table related to the mattress used on the patient table.
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