RAYSEARCH LABORATORIES AB - RayStation 4.0, 5SP2 - Class 2 Recall
RayStation 4.0 to RayStation 5 Service Pack 2 - 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 - Class 2 Recall
RayStation 8B, UDI # 07350002010129 - 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 7 - Class 2 Recall
RayStation 7, UDI # 07350002010068 - 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 SP1 - Class 2 Recall
RayStation 9B Service Pack 1, UDI # 07350002010297 - 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 9A - Class 2 Recall
RayStation 9A, UDI # 07350002010174 - 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 5SP3 - Class 2 Recall
RayStation 5 Service Pack 3, UDI # 07350002010020 - 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 - Class 2 Recall
RayStation 8A, UDI # 07350002010112 - 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 SP1 - Class 2 Recall
RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - 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 - Class 2 Recall
RayStation 6, UDI # 07350002010013 - 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
Elekta, Inc. - Elekta Unity - Class 2 Recall
Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 6, 2020 Category: Medical Devices Source Type: alerts
Beckman Coulter Inc. - Access GI Monitor - Class 2 Recall
Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2020 Category: Medical Devices Source Type: alerts
Merit Medical Systems, Inc. - DFINE Vertebral Assemblies - Class 2 Recall
DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2020 Category: Medical Devices Source Type: alerts
Merit Medical Systems, Inc. - DFINE Vertebral Hydraulic Assemblies - Class 2 Recall
DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 22, 2020 Category: Medical Devices Source Type: alerts
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
