65 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A; 3) NxStage One, Model Numbers: NX1000-3 and NX1000-3-A; 4) NxStage One, Model Numbers: NX1000-10 and NX1000-10-A;
FDA Recall
Terminated
·NxStage Medical, Inc.·Product code PEV·August 27, 2019
731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. They are appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an MRI conditional label, they are suitable for use in an MRI environment with appropriate precautions. The ventilators are intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers. The EMV+¿ and Eagle II (with and without MRI label) have a full range of ventilation modes (AC, SIMV with or without PS, CPAP with or without PS with PPC or NPPV-PPV). The AEV¿ provides specific modes consistent with pre-hospital care provider s operating procedures (AC, CPAP with PS and NPPV-PPV). The ZOLL ventilators are a small, extremely durable, full-featured portable mechanical ventilator designed to operate in hospitals or severe and under-resourced environments. It can be used in prehospital (ALS, ATLS, ACLS), field hospitals, and hospital settings. Easy¿ to-use, durable,
FDA Enforcement
Class II
·Terminated·ZOLL Medical Corporation·March 7, 2018
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
FDA Enforcement
Class II
·Terminated·Derma Pen, LLC·September 16, 2015
Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with optimized PET technology.
FDA Recall
Terminated
·Naviscan PET Systems·Product code KPS·June 19, 2008
PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging.
FDA Recall
Terminated
·Naviscan PET Systems·Product code KPS·August 1, 2007
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
FDA Recall
Terminated
·Derma Pen, LLC·Product code PIU·February 5, 2015
RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·May 18, 2020
RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·May 18, 2020
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.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·May 18, 2020
RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·May 18, 2020
RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·May 18, 2020
RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·May 18, 2020
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.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·May 18, 2020
RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·May 18, 2020
RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·May 18, 2020
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·May 18, 2020
RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·May 18, 2020
RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·May 18, 2020
RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·May 18, 2020
RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
FDA Recall
Terminated
·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·May 18, 2020