SmartPath to dStream for 1.5T, 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
Achieva 3.0T for PET, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Class I - Dangerous
Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles. The sterility of the biopsy needles has not been affected. This issue has been reported from one site.
MR 5300, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Ingenia Ambition X, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Trilogy EV300, 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.
Intera 1.5T Power/Pulsar, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
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.
Intera 0.5T Standard, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Trilogy Evo, 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
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Ingenia 1.5T, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Dr¿ger Perseus A500 Anesthesia Workstation
Draeger Medical
Class I - Dangerous
Unexpected shutdown while operating on battery power.
Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E
Smiths Medical ASD
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.
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
GYROSCAN T10-NT, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Intera 3.0T Quasar Dual, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Ingenia 3.0T, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.
Ingenia Ambition S, Magnetic Resonance System.
Philips North America
Class I - Dangerous
Patient support table floor plate may be incorrectly installed.