ICU Medical, Inc. - ChemoLock Closed System Drug Transfer Device - Class 2 Recall
3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, REF: CH2010; 20mL Syringe w/Spinning Spiros, Red Cap, REF: CH2020; 30mL Syringe w/Spinning Spiros, Red Cap, REF: CH2030; 60mL Syringe w/Spinning Spiros, Red Cap, REF: CH2060; 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger, REF: CH3011; 31" (79 cm) Appx 3.3 ml, Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros w/Red Cap, Hanger, REF: CH3011-C; 40 IN (102 cm) App 4.8 ml, Admin Set, 20 Drop, 2 Spiros, ...
Source: Medical Device Recalls - December 24, 2020 Category: Medical Devices Source Type: alerts
FLUDEOXYGLUCOSE F-18 injection [Barbara Ann Karmanos Cancer Hospital]
Updated Date: Fri, 18 Dec 2020 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 18, 2020 Category: Drugs & Pharmacology Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation - Class 2 Recall
RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 21, 2020 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - uMI 550 PET/CT System - Class 2 Recall
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - November 13, 2020 Category: Medical Devices Source Type: alerts
Boston Scientific Corporation - WallFlexTM Biliary RX Fully Covered Stent System RMV - Class 2 Recall
WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 12, 2020 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayCare - Class 2 Recall
RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 28, 2020 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - Positron Emission Tomography and Computed Tomography System - Class 2 Recall
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 19, 2020 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - uMI 550 - Class 2 Recall
uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 14, 2020 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - uEXPLORER - Class 2 Recall
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 14, 2020 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation 8B SP1 - Class 2 Recall
RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation 6 SP3 - Class 2 Recall
RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation SP2 - Class 2 Recall
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation 9B - Class 2 Recall
RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation 8A SP1 - Class 2 Recall
RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation 8B SP2 - Class 2 Recall
RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 11, 2020 Category: Medical Devices Source Type: alerts
