UROSKOP Omnia Max. Model Number: 10762473
Siemens Medical Solutions USA
Class I - Dangerous
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Lago X
Spectral Instruments
Class I - Dangerous
The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
UROSKOP Omnia. Model Number: 10094910
Siemens Medical Solutions USA
Class I - Dangerous
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-2.
Fresenius Medical Care Holdings
Class I - Dangerous
Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
Class I - Dangerous
Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ultimately lead to misdiagnosis of seizure location in neonates monitored with this device.
Intera 1.5T Achieva Nova-Dual Product Number: 781173;
Philips North America
Class I - Dangerous
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Due to non-sterile products being labeled as sterile
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
BD SWITZERLAND SARL
Class I - Dangerous
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Class I - Dangerous
Software issue that could potentially lead to the device tipping over from Balance Mode.
Class I - Dangerous
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Class I - Dangerous
Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
Baxter Healthcare
Class I - Dangerous
The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive heat and user burns.
Intera 1.5T Explorer/Nova Dual Product Number: 781108;
Philips North America
Class I - Dangerous
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
SmartPath to dStream for 1.5T¿; Product Number: 782146;
Philips North America
Class I - Dangerous
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
Intera 1.5T Achieva IT Nova Product Number: 781175
Philips North America
Class I - Dangerous
identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
BD SWITZERLAND SARL
Class I - Dangerous
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Contamac Solutions
Class I - Dangerous
Contact lens insertion solution may lack sterility.
Class I - Dangerous
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
Class I - Dangerous
A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Stryker GmbH
Class I - Dangerous
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.