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).
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
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
Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
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).
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Non-medical laser products which were determined to not be in compliance with 21 C.F.R. Âŋ 1010.2 in that they currently do not bear the required certification label.
Siemens Healthcare Diagnostics
The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.
Philips North America
Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
FUJIFILM Healthcare Americas
AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).
Jiangsu Shenli Medical Production Co.
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Siemens Healthcare Diagnostics
The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab.
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