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Philips North America Recalls

530 recalls on record · April 5, 2017 to July 1, 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 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: Upgrade to MR 7700; Model Number: 782130;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 28, 2025Medical DevicesFDA
Philips North America Llc recalls Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
Hazard: Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
May 14, 2025Medical DevicesFDA
Philips North America Llc recalls Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub
Hazard: Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
April 30, 2025Medical DevicesFDA
Philips North America Llc recalls Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Hazard: Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.
April 30, 2025Medical DevicesFDA
Philips North America Llc recalls Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic,
Hazard: A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
April 30, 2025Medical DevicesFDA
Philips North America Llc recalls Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, in
Hazard: A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
April 30, 2025Medical DevicesFDA
Philips North America Llc recalls Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, i
Hazard: A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
April 23, 2025Medical DevicesFDA
Philips North America Llc recalls Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.
Hazard: Potential for collimator to fall as a result of incorrect installation.
April 23, 2025Medical DevicesFDA
Philips North America Llc recalls Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
Hazard: Potential for collimator to fall as a result of incorrect installation.
February 12, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX550. Model Number: 866066
Hazard: Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
February 12, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX500. Model Number: 866064
Hazard: Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
February 12, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX450. Model Number: 866062
Hazard: Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
February 12, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliVue Patient Monitor MX400. Model Number: 866060
Hazard: Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
February 12, 2025Medical DevicesFDA
Philips North America Llc recalls IntelliBridge EC10 Module. Model Number: 865115
Hazard: Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.
December 25, 2024Medical DevicesFDA
Philips North America Llc recalls Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Hazard: The following four issues are included: 1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming to another Access Point potentially causing the client device to appear to drop out from the network. 2. if the Access Point experiences a disconnection from the Access Point Controller exceeding 4 minutes, the Access Point may not transition through the desired state to all for clean reconnection of the client radio link. 3. Potential to experience higher than expected data dropouts, device disassociations/reassociations for their wireless clients, and frequent "Loss of AP" alerts. 4. Potential for the Smart-hopping Access Point is affected by a software issue where the Access Point will resent after 82.85 days when the frame counter reaches its limit. This causes the latest synchronization check to fail and potential for loss of patient data.
December 11, 2024Medical DevicesFDA
Philips North America Llc recalls Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Hazard: Potential for a plan box not updated issue during Interventional procedure with Spectral CT that may lead to a collision with the operator or with the needle placed inside the patient, and an incorrect patient ID software issue that may lead to misdiagnosis.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls ST SENSE Breast Dx Coil
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls ST SENSE Breast Coil
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls SENSE Breast Coil 3.0T 7ch
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls SENSE Breast Coil
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls Mammotrak Interventional Coil 3.0T
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls Mammotrak Diagnostic Coil 3.0T
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls Mammotrak Interventional Coil 1.5T
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls Mammotrak Diagnostic Coil 1.5T
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls dS Breast 7ch 3.0T
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.
December 4, 2024Medical DevicesFDA
Philips North America Llc recalls dS Breast 7ch 1.5T
Hazard: Potential safety issue where a patient may be harmed while preparing for or during a scan.