Philips North America Llc recalls
34 recalls on record · FDA
Every recall we have on record for Philips North America Llc, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Brilliance iCT; Product Code (REF): 728306;
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 fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
Spectral CT; Product Code (REF): 728333;
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 fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.
IntelliVue MP90. Product Number: M8010A.
Potential issue where the IntelliVue monitors did not alarm.
IntelliVue MP30. Product Number: M8002A.
Potential issue where the IntelliVue monitors did not alarm.
IntelliVue Patient Monitor MX800. Product Number: 865240.
Potential issue where the IntelliVue monitors did not alarm.
Spectral CT. Computed tomography X-ray system.
Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional software issues that affect CT performance.
Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub…
Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
dS Breast 16ch 1.5T
Potential safety issue where a patient may be harmed while preparing for or during a scan.
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and…
Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.
HA FlexTrak II-Patient transport functionality to transport the patient from the…
Oil may leak from the HA FlexTrack Trolley onto the floor when pressing the hydraulic pedal, resulting in a potential slipping/falling hazard
Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; …
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 hospital's technical room, resulting in Smoke and/or fire
MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems…
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 hospital's technical room, resulting in Smoke and/or fire
Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4)…
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 hospital's technical room, resulting in Smoke and/or fire
Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems…
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 hospital's technical room, resulting in Smoke and/or fire
SmartPath to dStream for 3.0T Model Number (REF): 782145
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 hospital's technical room, resulting in Smoke and/or fire
Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
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 hospital's technical room, resulting in Smoke and/or fire
Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical…
Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation
Patient Information Center iX and Patient Information Center iX Expand, Software Version…
Event Catalog information does not save when copied and transferred from one unit to another.
Ingenia 1.5T S, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Achieva 1.5T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Intera 1.5T Omni/Stellar, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Achieva 3.0T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
GYROSCAN T5-NT, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Intera 1.5T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Intera 1.5T Achieva Nova, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and…
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 secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.
DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export…
Potential for units suspended on the ceiling to fail and fall.
CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
Potential for units suspended on the ceiling to fail and fall.
DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export…
Potential for units suspended on the ceiling to fail and fall.
DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export…
Potential for units suspended on the ceiling to fail and fall.
Patient Information Center iX with Software Version Number 4.x in the following: …
Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardware to restart and continue central patient monitoring. Potential for a delay in the detection of a change or deterioration in the condition of one or more patients
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
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 the modified labeling cannot be distributed or sold without new 510(k) clearance.