Medical equipment, implants, and diagnostic devices
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Philips North America
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
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Philips North America
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
Philips North America
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
Maquet Medical Systems USA
The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.
Medtronic Perfusion Systems
Potential for unsealed sterile packing.
Boston Scientific
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Philips North America
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
Medtronic Perfusion Systems
Potential for unsealed sterile packing.
Boston Scientific
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error involving perforation of the inner channel of the catheter during stylet insertion.
Boston Scientific
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Philips North America
Event Catalog information does not save when copied and transferred from one unit to another.
Medtronic Perfusion Systems
Potential for unsealed sterile packing.
Potential for unsealed sterile packing.
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
MEDLINE INDUSTRIES, LP - Northfield
Products have a lack of sterility assurance.