Recall archive
73 recalls · page 2 of 4
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 Jan 24, 2024
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Multiple software issues that affect device functionality.
FDA (openFDA device enforcement)
Reported Dec 27, 2023
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product details — Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect…
FDA (openFDA device enforcement)
Reported Dec 20, 2023
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR)…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips North America LLC
Matched: Brand · Product · Product details — Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of…
FDA (openFDA device enforcement)
Reported Nov 29, 2023
Achieva 1.5T
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Potential component failure in the Gradient Coil could product smoke and/or fire.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 22, 2023
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 15, 2023
CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Potential for units suspended on the ceiling to fail and fall.
9 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 11, 2023
EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 27, 2023
Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require…
FDA (openFDA device enforcement)
Reported Jul 5, 2023
DigitalDiagnost C90, Model No. 712034 and 712035
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — There is a software login in issue that may prevent the user from logging in.
FDA (openFDA device enforcement)
Reported Jun 7, 2023
EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 24, 2023
Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment…
FDA (openFDA device enforcement)
Reported May 10, 2023
Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a…
FDA (openFDA device enforcement)
Reported Apr 19, 2023
CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 18, 2023
Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN:…
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 — Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the…
FDA (openFDA device enforcement)
Reported Dec 14, 2022
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand · Product · Product details — Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 12, 2022
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power…
FDA (openFDA device enforcement)
Reported Sep 7, 2022
DigitalDiagnost C50 1.1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
Matched: Brand — Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect…
FDA (openFDA device enforcement)
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