Recall archive
71 recalls · page 3 of 3
Reported Mar 16, 2022
Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 9, 2022
eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — eCareManager (eCM) Sentry Score software not approved for use
FDA (openFDA device enforcement)
Reported Jan 26, 2022
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Reason for recall — After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 19, 2022
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — (1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 29, 2021
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come…
FDA (openFDA device enforcement)
Reported Dec 15, 2021
BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil)…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 1, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 Continuous…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 17, 2021
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at the same time, the geometry may stop…
FDA (openFDA device enforcement)
Reported Oct 20, 2021
Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — Customers were not notified of previous recalls associated with various defibrillator models.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 22, 2021
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 15, 2021
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 1, 2021
Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
6 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 25, 2021
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 7, 2021
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the…
11 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 16, 2021
Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These blocks are used to allow the magnets to be moved in…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 9, 2021
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
FDA (openFDA device enforcement)
Reported Jun 2, 2021
IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
FDA (openFDA device enforcement)
Reported May 5, 2021
Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood…
FDA (openFDA device enforcement)
Reported Mar 24, 2021
Incisive CT Computed Tomography X-ray System Model: 728143
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with…
FDA (openFDA device enforcement)
Reported Dec 16, 2020
Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2020
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 2, 2019
Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child…
FDA (openFDA device enforcement)
Reported Dec 19, 2018
HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Affected lithium-ion batteries may contain a defective component (Thermal Cut-off or TCO). Should the component fail, the battery will no longer…
FDA (openFDA device enforcement)
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