Ingenia Elition X, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Enterprise 1.5T, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Class I - Dangerous
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Class I - Dangerous
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
MR 7700, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
GYROSCAN T5, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Intera Achieva 1.5T Pulsar, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Achieva 3.0TX for PET, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Class I - Dangerous
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
Intera CV, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Philips Respironics
Class I - Dangerous
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Class I - Dangerous
Their is a potential that Oximeter may automatically power off and on resulting in loss of monitoring.
Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message TUBE HOT, have a break . the system cannot be operated normally, may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
Achieva 1.5T Conversion, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Intera 1.5T R11, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Achieva 1.5T Initial, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Intera 1.0T Power/Pulsar, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Evolution Upgrade 3.0T, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
Smith & Nephew Medical
Class I - Dangerous
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump