PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. - Azurion R2.1 - Class 2 Recall
Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 23, 2024 Category: Medical Devices Source Type: alerts
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. - Azurion R2.1 - Class 2 Recall
Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 23, 2024 Category: Medical Devices Source Type: alerts
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. - Azurion R2.1 - Class 2 Recall
Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722227 (2) 722228 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 23, 2024 Category: Medical Devices Source Type: alerts
Philips North America Llc - Philips Azurion 7 M20 - Class 2 Recall
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. "Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: "The Azurion series can be used in a hybrid Operation Room. "The Azurion series contain a number of features to support a flexible and patient centric procedural workflow. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 15, 2021 Category: Medical Devices Source Type: alerts
Brainlab AG - Brainlab Cranial Image Guided Surgery System / Instrument, Stereotaxic - Class 2 Recall
Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - October 7, 2020 Category: Medical Devices Source Type: alerts
Philips North America, LLC - Phillips Azurion 7 M20 - Class 2 Recall
Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 25, 2020 Category: Medical Devices Source Type: alerts
Philips North America, LLC - Class 2 Recall
Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20 Models: 722063, 722064, 722067, 722068, 722078, 722079. Product Usage: The Azurion series (within the limits of the used Operating Room table) are intended for use to perform: Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures Cardiac imaging applications including diagnostics, interventi...
Source: Medical Device Recalls - August 7, 2019 Category: Medical Devices Source Type: alerts
Brainlab AG - Spine & Trauma 3D Navigation 1.0 - Class 1 Recall
Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 16, 2019 Category: Medical Devices Source Type: alerts
Terumo Cardiovascular Systems Corporation - VirtuoSaph Plus Endoscopic Vessel Harvesting System - Class 2 Recall
VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surge1y for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requit¿ing blunt dissection of tissue including dissection of blood vessels and dissection of blood vessels of the extremities. Extremity procedures include tissue dissection and/or...
Source: Medical Device Recalls - October 25, 2018 Category: Medical Devices Source Type: alerts
Intuitive Surgical, Inc. - da Vinci Si/X/Xi Surgical System - Class 2 Recall
da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasive surgery. All three components must be powered on for the system to be functional. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 27, 2018 Category: Medical Devices Source Type: alerts
Ethicon, Inc. - Dermabond Prineo System - Class 2 Recall
DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND PRINEO System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound durinQ application of the liquid adhesive (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 22, 2018 Category: Medical Devices Source Type: alerts
Philips Electronics North America Corporation - Philips Allura Xper R9 and Azurion R1.1 - Class 2 Recall
Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures ( such as PTCA, stent placing, atherectomies), pacemaker implantations, and ele...
Source: Medical Device Recalls - December 19, 2017 Category: Medical Devices Source Type: alerts
Stryker Instruments Div. of Stryker Corporation - MIS (Minimally Invasive Surgery) Toolsteel Burs - Class 2 Recall
8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 22, 2016 Category: Medical Equipment Source Type: alerts
Stryker Instruments Div. of Stryker Corporation - MIS (Minimally Invasive Surgery) Toolsteel Burs - Class 2 Recall
8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 22, 2016 Category: Medical Equipment Source Type: alerts
Stryker Instruments Div. of Stryker Corporation - MIS (Minimally Invasive Surgery) Toolsteel Burs - Class 2 Recall
8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the head of the bur on the other end. " A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 22, 2016 Category: Medical Equipment Source Type: alerts
