Medical equipment, implants, and diagnostic devices
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
Integra LifeSciences
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Fresenius Medical Care Holdings
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
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).
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).
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).
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).
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).