Recall archive
101 recalls · page 1 of 5
Reported Nov 4, 2026
Model Number: 712010.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand — Potential for the device to fail immediately after an exposure, causing the system to remain stationary.
FDA (weekly enforcement report)
Reported Oct 28, 2026Updated Nov 2, 2026
Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand · Product · Product details — Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure,…
FDA (openFDA device enforcement)
Reported Oct 7, 2026Updated Oct 13, 2026
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold…
FDA (openFDA device enforcement)
Reported Oct 7, 2026Updated Oct 13, 2026
Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 782103 (3.0T), 4. 781271 (3.0T…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand — When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that…
10 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 23, 2026Updated Sep 29, 2026
Philips Patient Information Center iX REF:866389
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand · Product · Product details — Due to software malfunction, patient information system may freeze and become unresponsive.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 9, 2026Updated Sep 14, 2026
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details · Reason for recall — Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Cardiac Workstation 5000. Product Number: 860439.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Device will intermittently provide inaccurate data related to native heart rate.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 1, 2026
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 17, 2026
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand…
FDA (openFDA device enforcement)
Reported May 6, 2026
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand · Product · Product details — The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm,…
18 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 18, 2026
Brilliance iCT; Product Code (REF): 728306;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 4, 2026
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand — The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 28, 2026
Patient Information Center iX; Software Version Number: 4.5.0
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand — A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the…
FDA (openFDA device enforcement)
Reported Jan 14, 2026
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal…
FDA (openFDA device enforcement)
Reported Dec 17, 2025
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand · Reason for recall — Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The…
FDA (openFDA device enforcement)
Reported Dec 10, 2025
IntelliVue MP2. Product Number: M8102A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Potential issue where the IntelliVue monitors did not alarm.
23 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 22, 2025
Cardiac Workstation 5000; Model Number: 860439;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand — Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 1, 2025
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
9 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 6, 2025
Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand — The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke…
18 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 2, 2025
Spectral CT. Computed tomography X-ray system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or…
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Achieva XR Product Numbers: (1) 781153, (2) 781253;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand — identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a…
8 more products in this recall
FDA (openFDA device enforcement)
Reported May 28, 2025
Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
17 more products in this recall
FDA (openFDA device enforcement)
Reported May 14, 2025
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
FDA (openFDA device enforcement)
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