Recall archive
101 recalls · page 2 of 5
Reported Apr 30, 2025
Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — 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.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — Potential for collimator to fall as a result of incorrect installation.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2025
IntelliBridge EC10 Module. Model Number: 865115
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — The following four issues are included: 1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming…
FDA (openFDA device enforcement)
Reported Dec 11, 2024
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Dec 4, 2024
Achieva TX Interventional Coil 3.0T
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Potential safety issue where a patient may be harmed while preparing for or during a scan.
12 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 16, 2024
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG…
FDA (openFDA device enforcement)
Reported Oct 16, 2024
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand — During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease…
FDA (openFDA device enforcement)
Reported Oct 9, 2024
DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — If the DIVA touch display generates touch inputs without user interaction, due to possibility of the erroneous acknowledgement of a patient alarm,…
FDA (openFDA device enforcement)
Reported Oct 9, 2024
IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand — The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue…
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2024
IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand · Reason for recall — During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable…
FDA (openFDA device enforcement)
Reported Aug 14, 2024
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Reason for recall — Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Potential for inaccurate fetal heart rate measurements when monitoring multiples.
FDA (openFDA device enforcement)
Reported Jul 3, 2024
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips North America LLC
Matched: Brand · Product · Product details — Potential for coils to heat up and harm patients (burn).
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2024
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 29, 2024
Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the…
31 more products in this recall
FDA (openFDA device enforcement)
Reported May 22, 2024
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Event Catalog information does not save when copied and transferred from one unit to another.
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 8, 2024
The Oncology Essentials Package of the Spectral CT imaging system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Potential for third party oncology marking laser to be reflected off the gantry cover surface, which can potentially lead to misdiagnosis and…
FDA (openFDA device enforcement)
Reported May 1, 2024
Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the…
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Achieva 1.5T, Magnetic Resonance System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Patient support table floor plate may be incorrectly installed.
40 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 17, 2024
PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand · Product · Product details — Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide…
FDA (openFDA device enforcement)
Reported Apr 3, 2024
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand — It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 21, 2024
ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand · Reason for recall — Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s radiography (RAD) images when starting the next…
1 more product in this recall
FDA (openFDA device enforcement)
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