Aomori Olympus Co., Ltd. - NA201SX4022B ASPIRATION NEEDLE ViziShot 22G - Class 2 Recall
NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G, model no. NA-201SX-4022-B - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2021 Category: Medical Devices Source Type: alerts
Aomori Olympus Co., Ltd. - NA201SX4022ASPIRATION NEEDLE VIZISHOT 22G - Class 2 Recall
NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2021 Category: Medical Devices Source Type: alerts
Aomori Olympus Co., Ltd. - NA200H8022 22G EZSHOT ASPIRATION NEEDLE - Class 2 Recall
NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the gastrointestinal tract. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2021 Category: Medical Devices Source Type: alerts
Aomori Olympus Co., Ltd. - NA201SX4021 ASPIRATION NEEDLE VIZISHOT 21G - Class 2 Recall
NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2021 Category: Medical Devices Source Type: alerts
Aomori Olympus Co., Ltd. - NA201SX4022C ASPIRATION NEEDLE ViziShot 22G w/o stylet - Class 2 Recall
NA-201SX-4022-C ASPIRATION NEEDLE ViziShot 22G w/o stylet, model no. NA-201SX-4022-C - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2021 Category: Medical Devices Source Type: alerts
Philips Ultrasound Inc - Philips EPIQ Diagnostic Ultrasound System - Class 2 Recall
Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 4, 2021 Category: Medical Devices Source Type: alerts
Philips Ultrasound Inc - Diagnostic Ultrasound System Ultrasound Pulsed Doppler Imaging - Class 2 Recall
Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA MOD EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA MOD EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA MOD EPIQ DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only,100-240V~50/60 Hz, 600VA (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 3, 2021 Category: Medical Devices Source Type: alerts
Philips Ultrasound Inc - System, Imaging, Pulsed Doppler, Ultrasonic - Class 2 Recall
All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD - EPIQ 5 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 7 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 100-240V 50/60 Hz, 600 VA MOD - Affinity 30 GMDN - 40761 100-240V 50/60 Hz, 450 VA MOD - Affinity 50 GMDN - 40761 100-240V 50/60 Hz, 450 VA MOD - Affinity 70 GMDN - 40761 100-240V 50/60 Hz, 450 VA (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 15, 2021 Category: Medical Devices Source Type: alerts
HAND WIPES (benzalkonium chloride) swab [Advanced Ultrasound Solutions Inc.]
Updated Date: Mon, 11 Jan 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 11, 2021 Category: Drugs & Pharmacology Source Type: alerts
Bioventus, LLC - EXOGEN Ultrasound Coupling Gel - Class 2 Recall
EXOGEN Ultrasound Coupling Gel (Source: Medical Device Recalls)
Source: Medical Device Recalls - January 10, 2021 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - EKOS Control System - Class 2 Recall
EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular treatment site. The reusable Control Unit provides power to the device and provides the user interface for operator control. A reusable, non-sterile connector interface cable (CIC) connects the Control Unit to the Ultrasonic Core and Infusion Catheter. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 18, 2020 Category: Medical Devices Source Type: alerts
Olympus Corporation of the Americas - Ultrasonic Gastrovideoscope/ Endoscopic Ultrasound Endoscopes - Class 2 Recall
Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 28, 2020 Category: Medical Devices Source Type: alerts
Olympus Corporation of the Americas - Ultrasonic Gastrovideoscope/ Endoscopic Ultrasound Endoscopes - Class 2 Recall
Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 28, 2020 Category: Medical Devices Source Type: alerts
Olympus Corporation of the Americas - Ultrasonic Gastrovideoscope/ Endoscopic Ultrasound Endoscopes - Class 2 Recall
Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 28, 2020 Category: Medical Devices Source Type: alerts
Olympus Corporation of the Americas - Ultrasonic Gastrovideoscope/ Endoscopic Ultrasound Endoscopes - Class 2 Recall
Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 28, 2020 Category: Medical Devices Source Type: alerts
