Class I - Dangerous
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
There is the potential for the front plexiglass door of the automated slide processing system to break causing potential injury.
BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324
CareFusion 303
Class I - Dangerous
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN Model/Catalog Number: 91831 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Brand Name: MEDLINE Product Name: SYR 10ML L/L RED Model/Catalog Number: 91830 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Brand Name: MEDLINE Product Name: SYR 10ML L/L PURPLE Model/Catalog Number: 91842 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
Philips North America
Class I - Dangerous
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
Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR12L Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Brand Name: MEDLINE Product Name: SYR 60ML L/S Model/Catalog Number: 83079 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Merit Medical Systems
Class I - Dangerous
Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator.
Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L RED Model/Catalog Number: 91878 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW Model/Catalog Number: 91839 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
Blood Pump Rotor, Model Number: F40015481 Rev A
Fresenius Medical Care Holdings
Class I - Dangerous
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.
MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781483
Philips North America
Class I - Dangerous
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
Brand Name: MEDLINE Product Name: SYR 20ML L/L GREEN Model/Catalog Number: 91836 Product Description: NON-Sterile syringes without needles for single use Component: No
Jiangsu Shenli Medical Production Co.
Class I - Dangerous
Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
BiPAP V30 Auto Ventilator, Part Number 1111178
Philips Respironics
Class I - Dangerous
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359
Philips North America
Class I - Dangerous
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
Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356
Philips North America
Class I - Dangerous
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