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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V Recalls
209 recalls on record · February 23, 2022 to August 19, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 1.5T, Model Numbers: 781195 and 781295;
Hazard: 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.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 1.0T Power/Pulsar, Model Number: 781103;
Hazard: 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.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 1.0T Omni/Stellar, Model Number: 781102;
Hazard: 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.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Intera 0.5T Standard, Model Number: 781101;
Hazard: 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.
May 21, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Enterprise 1.5T, Model Number: 781145;
Hazard: 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.
May 14, 2025Medical DevicesFDA
Philips Medical Systems Nederland B.V. recalls IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Hazard: 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.
April 30, 2025Medical DevicesFDA
Philips Medical Systems Nederland B.V. recalls Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as w
Hazard: Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
March 19, 2025Medical DevicesFDA
Philips Medical Systems Nederland B.V. recalls Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Hazard: Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
March 12, 2025Medical DevicesFDA
Philips Medical Systems Nederland B.V. recalls Philips IntelliSpace Cardiovascular software, Model 830089.
Hazard: Study data is not able to be archived, copied, or exported with the cardiovascular software version.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10C; Catalog number: 722001
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura CV20; Catalog numbers: 722031
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20/20; Catalog numbers: 722038
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20/15; Catalog numbers: 722058
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20/10; Catalog numbers: 722029
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 26, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
Hazard: Possibility of the patient falling from the table related to the mattress used on the patient table.
February 12, 2025Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223
Hazard: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel