Medline Industries Inc - Medline convenience kits containing - Class 2 Recall
Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER PACK DYNJ30056J ARTHRO/SHOULDER PACK DYNJ30056K ARTHRO/SHOULDER PACK DYNJ30056L ARTHRO/SHOULDER PACK DYNJ30056M BODY PACK DYNJ55107A BODY PACK DYNJ55107C BODY PACK DYNJ55107D C SECTION CDS CDS984613D C SECTION CDS CDS830172I C SECTION CDS CDS984613F C SECTION CDS CDS830172J C SECTION PACK CMPJ17294I C SECTION PACK-LF DYNJ64834 CARDIAC A & B SJ PACK DY...
Source: Medical Device Recalls - May 16, 2020 Category: Medical Devices Source Type: alerts
Shanghai United Imaging Healthcare Co., Ltd. - uMI 550 PET/CT System - Class 2 Recall
Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 - 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 - April 16, 2020 Category: Medical Devices Source Type: alerts
Life Technologies Corporation - Oncomine Target Dx Test - Class 2 Recall
Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2020 Category: Medical Devices Source Type: alerts
Life Technologies Corporation - Ion Torrent Dx No Template Control Kit - Class 2 Recall
Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog Number: A32444 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2020 Category: Medical Devices Source Type: alerts
Life Technologies Corporation - Oncomine Target Dx Test - Class 2 Recall
Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2020 Category: Medical Devices Source Type: alerts
Life Technologies Corporation - Oncomine Target Dx Test - Class 2 Recall
Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 15, 2020 Category: Medical Devices Source Type: alerts
Impac Medical Systems, Inc. - MOSAIQ - Class 2 Recall
MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2020 Category: Medical Devices Source Type: alerts
RAYSEARCH LABORATORIES AB - RayStation/RayPlan - Class 2 Recall
RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - 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 - March 27, 2020 Category: Medical Devices Source Type: alerts
Roche Diagnostics Operations, Inc. - Elecsys CA 199 - Class 2 Recall
Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 6, 2020 Category: Medical Devices Source Type: alerts
Siemens Medical Solutions USA, Inc - COHERENCE Oncologist - Class 2 Recall
COHERENCE Oncologist, Model Nos. 07333680 & 07351898 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 22, 2020 Category: Medical Devices Source Type: alerts
Centurion Medical Products Corporation - Centurion Dressing Change Kits - Class 2 Recall
Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1586C CENTRAL LINE DRESSING NGE TRAY DYNDC1597A CVC DRESSING CHANGE TRAY DYNDC1796C TRAY, CENTRAL LINE DYNDC1796C TRAY, CENTRAL LINE DYNDC1800 TRAY,PORT-A-CATH ACCESS DYNDC1855A CVC DRESSING CHANGE KIT DYNDC1870A SMALL DRESSING KIT DYNDC1945B PORT ACCESS KIT DYNDC1980B CVC DRESSING CHANGE KIT DYNDC1980B CVC DRESSING CHANGE KIT DYNDC1993 PORT ACCESS TRAY DYNDC1993 PORT ACCESS TRAY DYNDC1993 PORT ACCESS TRAY DYNDC1993 PORT ACCESS TRAY DYNDC1996B CENTRAL LINE DRESSING CHANGE DYNDC2004A IVAD KIT DYNDC20...
Source: Medical Device Recalls - February 6, 2020 Category: Medical Devices Source Type: alerts
Angiodynamics, Inc. - ORAtrac System - Class 2 Recall
MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 20, 2019 Category: Medical Devices Source Type: alerts
Angiodynamics, Inc. - ORAtrac System - Class 2 Recall
MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 20, 2019 Category: Medical Devices Source Type: alerts
Angiodynamics, Inc. - OARtrac System - Class 2 Recall
MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 20, 2019 Category: Medical Devices Source Type: alerts
Angiodynamics, Inc. - OARtrac System - Class 2 Recall
OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 20, 2019 Category: Medical Devices Source Type: alerts
