BEUDAMED
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    EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a single patient IV administration bag.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·July 9, 2014

    NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-0523 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.

    FDA Enforcement
    Class II ·Terminated·Aomori Olympus Co., Ltd.·February 17, 2021

    Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·February 25, 2015

    BHM Medical Scales, 800 lb. scale weight limit; Part Number 700.00510, Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5; These scales were sold for installation on or as a component of the following patient lifts: a) Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5: Part Number: 88570101, Ergolift 600 BAL. Wide Opening Patient Lift; Part Number : ERGOLIFT-600+SC, Ergolift 600 Lbs with Scale Patient Lift; Part Number: ERGOLIFT-2 + SC, Ergolift 400 Lbs with Scale Patient Lift; b) Manufactured for Sunrise Medical, Longmont, CO 80503: Part Number : 700.05610.06, Hoyer-600 Spreader Bar with Scale; Part Number: 9600102.06, Hoyer-600 Sunrise Patient Lifter with Scale, Model HPL-600WBSC; Part Number: 9600132.06, Hoyer-600 Wide Opening Patient Lifter with Scale

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FRW·December 19, 2007

    EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a single patient IV administration bag.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code LHI·June 10, 2014

    Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·January 16, 2015

    Maxi Move, Model NDA0200-20 Batteries Pack; BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada J1X 5Y5 The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients.

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·November 5, 2008

    Ergolift 400 Lbs. Floor Lift, Manufactured by BHM Medical Inc., 2001 Tanguay, Magog, QC, Canada, J1X 5Y5; model/part numbers ERGOLIFT and ERGOLIFT-2 The equipment is intended to be used in hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients.

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·December 8, 2008

    BHM Reacher for Portable Ceiling Lifts; a portable ceiling lift accessory used to connect the lift to the BHM Track or KwikTrak Trolley; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The reacher comes in two models: part #700.08310 - 24'' handle length, and part #700.08320 - 36'' handle length

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·November 13, 2006

    Medi-Lifter III Plus Total Lift, Model 7000-2000 and Summit Total Lift, Model 4800-2000; patient lifts with mast scale (600 lbs. capacity); Mast scale is Intended to be used for weighing patients while in the lifter. Manufactured by Medi-Man Rehabilitation Products Inc., 6200A Tomken Road, Mississauga, Ontario, Canada L5T 1X7, now owned by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·April 10, 2008

    Nautica (GK) Mattress Stretcher, manufactured by Georg Kramer GES.M.B.H. & CO. KG A-4061 PASCH ING, Neuhauserweg 14 Austria. These mattress stretchers were sold for installation on or as a component of the following patient bath lifts: a) Manufactured by BHM Medical Inc., Magog, QC, Canada J1X 5Y5: Part number 88004051, Nautica Bath Lift System; b) Distributed by Whitehall Manufacturing, P.O. Box 3527, City of Industry, CA 91744, Manufactured by BHM Medical Inc., Canada: Part number 88004051.12, Nautica Bath Lift System

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·January 23, 2007

    The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation. After surgical implantation, the Medtronic Neurosurgery StrataMR valves provide a non-invasive method to address changing patient needs in the management of hydrocephalus. The valve design enables the physician to adjust the valve pressure/performance level using the Medtronic StrataMR Adjustment Tools. The StrataMR valves are intended to maintain performance level setting under magnetic resonance imaging (MRI) exposure when scanned in accordance with the MRI conditions in the labeling. The StrataMR valves, small and regular, provide the full range of performance levels: 0.5, 1.0, 1.5, 2.0, and 2.5. The currently set performance level is discernible through use of the Indicator Tool or by x-ray (for corresponding settings, refer to figure 6). The dome is designed to allow needle puncture via a 25-gauge or smaller noncoring needle. The StrataMR valve can be flushed in either the distal or proximal direction by percutaneous finger pressure. Occluders are located proximally and distally to the central reservoir on the StrataMR valve regular and only distally on the small model to facilitate selective flushing.

    FDA Enforcement
    Class I ·Terminated·Medtronic Neurosurgery·April 19, 2017

    BHM Kwiktrak Fixed Gate component of the Kwiktrak rail system used with the Maxi Sky 600 Ceiling Patient Lift; Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The fixed gate, part #700.11550, was sold in two kits: a) Part #700.11500 Kwiktrak Gate Kit composed of the fixed gate and a 3-contact interface kit part #700.15515, and b) Part #700-11505 Double Gate Kit composed of two fixed gates and 3-contact interface kits

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·October 23, 2006

    Kwiktrak Gate System; the rail system used with the Maxi Sky 600 Ceiling Patient Lift; The Kwiktrak Gate System consists of part 700.11560 - Kwiktrak gate motor box (serialized), part 700.11550 - Kwiktrak gate fixed box, part 700.11505 - Kwiktrak gate combination kit (includes 2 x 700.11550 and 2 x 700.11560), and part 700.11500 - Kwiktrak gate (includes 1 x 700.11550 and 1 x 700.11560) Manufactured by BMH Medical Inc., 2001 Tanguay Street , Magog, Quebec, Canada J1X 5Y5. The equipment is intended for transferring lifts from one system track to another.

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·August 1, 2008

    CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.

    FDA Recall
    Terminated ·GVI Technology Partners·Product code IYX·January 16, 2004

    SMV FX-40 Nuclear Camera

    FDA Recall
    Terminated ·General Electric Med Systems·Product code IYX·July 30, 2004

    SMV FX-80 Nuclear Camera

    FDA Recall
    Terminated ·General Electric Med Systems·Product code IYX·July 30, 2004

    No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAX·January 9, 2007

    Integrated Orbiter Single Detector General Purpose Gamma Camera System; Siemens Medical Systems, Inc., Nuclear Medicine Group, 2501 North Barrington Road, Hoffman Estates, IL 60195-5203

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYX·February 10, 2003

    Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines.

    FDA Recall
    Terminated ·A M Systems Inc·Product code BYX·August 10, 2018