Recall archive
101 recalls · page 3 of 5
Reported Feb 14, 2024
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Philips North America
Matched: Brand — Detector may unexpectedly fall due to a component failure. If the detector is positioned below center of gantry, there is a potential for abrasion,…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand — The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose…
11 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 31, 2024
Achieva 1.5T, Model No. 781178, 781196, 781296
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Philips North America
Matched: Brand — An incorrect electrical shock warning label may have been placed on the Liquid Cooling Cabinet (LCC) of affected MR systems. The caution symbol on…
5 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 Jan 24, 2024
Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand — If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
BrightView, Gamma Camera System, Product Code 882480.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand — While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which…
3 more products in this recall
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 22, 2023
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand — When preparing for CCT Fluoroscopy mode and activating the CCT foot pedal simultaneously, the operator may experience a software crash. This would…
1 more product 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 Nov 15, 2023
BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand · Product · Product details · Reason for recall — Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico…
5 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 Aug 16, 2023
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand — The system operator is able to bypass the SmokeDetector Interlock system locking mechanism after a smoke detection by power cycling the system.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 9, 2023
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
Matched: Brand — Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact…
3 more products in this recall
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 24, 2023
Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
Matched: Brand · Product · Product details — Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause…
4 more products in this recall
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)
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