June 5, 2024Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
Hazard: When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
June 5, 2024Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.
Hazard: When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.
June 5, 2024Medical DevicesFDA
Mirion Technologies (Capintec), Inc. recalls Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff
Hazard: Complaints of unexpected detachment of the collimator have been reported.
June 5, 2024Medical DevicesFDA
Mirion Technologies (Capintec), Inc. recalls Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe t
Hazard: Complaints of unexpected detachment of the collimator have been reported.
June 5, 2024Medical DevicesFDA
Mirion Technologies (Capintec), Inc. recalls Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
Hazard: Complaints of unexpected detachment of the collimator have been reported.
June 5, 2024Medical DevicesFDA
Covidien, LP recalls Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surg
Hazard: Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
June 5, 2024Medical DevicesFDA
Boston Scientific Neuromodulation Corporation recalls Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG K
Hazard: Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.
June 5, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF
Hazard: Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use.
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product Description: NON-Sterile syri
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Steri
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog Number: 91862 Product Description: NON-Ste
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE CONTRAST Model/Catalog Number: 91860 Product Description: NON-Ster
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M Product Description: NON-Sterile sy
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog Number: TS2260LB-M Product Description: NON-Ste
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Model/Catalog Number: TS2210B-M Product Description: NON-Ster
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number: TS3210L-M Product Description: NON-Ster
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: GMAX Product Name: SYR 60ML/LS syringe Model/Catalog Number: TS2260S-M Product Description: NON-Sterile s
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product Description: NON-Sterile s
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number: TS2212S-M Product Description: NON-Sterile s
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile s
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number: TS2260L-M Product Description: NON-Sterile s
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile s
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product Description: NON-Sterile s
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: GMAX Product Name: SYR 20ML/LL syringe Model/Catalog Number: TS2220L-M Product Description: NON-Sterile s
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile s
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M Product Description: NON-Sterile s
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: GMAX Product Name: SYR 6ML/LL syringe Model/Catalog Number: TS2206L-M Product Description: NON-Sterile sy
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product Description: NON-Sterile sy
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: GMAX Product Name: SYR 3ML/LL syringe Model/Catalog Number: TS2203L-M Product Description: NON-Sterile sy
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).
May 29, 2024Medical DevicesFDA
Jiangsu Shenli Medical Production Co., Ltd. recalls Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR
Hazard: Piston syringes sizes and configurations are out of the range of devices cleared under the firm's 510(k).