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).
Tornier S.A.S.
The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.
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).
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).
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
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
Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.
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).