Prodimed Plastimed Division - Prodimed Combicath Paediatric catheters - Class 2 Recall
Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 5, 2020 Category: Medical Devices Source Type: alerts
Prodimed Plastimed Division - Prodimed Combicath Paediatric catheters - Class 2 Recall
Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 5, 2020 Category: Medical Devices Source Type: alerts
Smiths Medical ASD Inc. - Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes - Class 2 Recall
Pediatric Adjustable Flange Tracheostomy Tube Cuffless (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 2, 2020 Category: Medical Devices Source Type: alerts
Mediana Co., Ltd. - DIRECT SUPPLY Attendant VITAL SIGNS MONITOR - Class 2 Recall
DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Siemens Artis zee/zeego & Artis Q/Q.zen - Class 2 Recall
Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model: 10848281; Artis Q biplane Model:10848282; Artis zee ceiling Model: 10094137; Artis zee floor Model: 10094135 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 10, 2020 Category: Medical Devices Source Type: alerts
Spacelabs Healthcare, Inc. - Spacelabs Healthcare Xhibit Central Station (96102) - Class 2 Recall
Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 5, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - ARTIS pheno - Class 2 Recall
ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 23, 2020 Category: Medical Devices Source Type: alerts
Access Scientific LLC - Safety Introducer - Class 2 Recall
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit. REF/UDI / 94124/10859821006480 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts
Intuitive Surgical, Inc. - daVinci XI Sureform 60 Reload - Class 2 Recall
daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 6, 2020 Category: Medical Devices Source Type: alerts
Intuitive Surgical, Inc. - daVinci XI Sureform 60 Reload - Class 2 Recall
daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 6, 2020 Category: Medical Devices Source Type: alerts
Radiometer Medical ApS - TCM4 Monitoring Systems - Class 2 Recall
TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 23, 2020 Category: Medical Devices Source Type: alerts
Karl Storz Endoscopy - KARL STORZ NEUROFIBERSCOPE - Class 2 Recall
Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 21, 2020 Category: Medical Devices Source Type: alerts
Butterfly Network, Inc. - Butterfly iQ - Class 2 Recall
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 18, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Artis Q - Class 2 Recall
Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 14, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - Artis zee/zeego - Class 2 Recall
Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 14, 2020 Category: Medical Devices Source Type: alerts
