85 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See attached IFU (IFU_Triathlon Total Knee_QIN 4376 Rev AB).
FDA Enforcement
Class II
·Terminated·Howmedica Osteonics Corp.·October 9, 2019
Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·January 14, 2015
IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.
FDA Enforcement
Class II
·Terminated·Trumpf Medical Systems, Inc.·January 14, 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
GE Healthcare Precision RXi 23A/ 32A Remote X-Ray Imaging R&F System. It is a remote analog R&F system consisting of a tilting table with integrated spot film device, 65 kW pulsing generator and high heat capacity X-Ray tube. The system can be configured to meet a wide variety of exams for various clinical applications with ether 23 cm image intensifier with 512x512 Image Chain or 32 cm Image intensifier with either 512x512 Image Chain or 1Kx 1K Image Chain.
FDA Recall
Terminated
·GE Healthcare·Product code JAA·December 18, 2007
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
ITW Dymon Medaphene Plus Disinfectant Spray, Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal, Staphylocidal, Tuberculocidal, packaged in 20-oz. steel aerosol cans, net wt 16-oz. (1-lb.), 12 cans/case, containing 0.19% o-phenylphenol and 68.00% ethyl alcohol, Product 34720. The firm name on the label is ITW Dymon, Olathe, KS. The product is also sold under the following private labels: (1) Renown Disinfectant Deodorant II, Product REN05013, Distributed by AmSan, LLC, Deerfield, IL; (2) Decon Aerosol Disinfectant, Catalog #8617, Manufactured For Decon Labs, Inc., Bryn Mawr, PA; (3) New Jax Medaphene Plus Disinfectant Spray, Sold By Newell Paper Company, Hattiesburg, MS, Columbus, MS, Meridian, MS; (4) San-O-Phene Plus Disinfectant Spray, Sold By San Joaquin Supply Co., Fresno, CA; (5) Sterling Quality Hospital Use Micro II Disinfectant Spray, Distributed By Sterling Sanitary Supply Corporation, Woodside, NY; (6) Ball-Phene Spray Disinfectant, Reorder #3U037, Manufactured for W.W. Grainger, Inc., Lake Forest, IL; (7) Area Two-In-One Disinfectant Spray Original, Sold By Area Distributors, Inc., Quincy, IL; (8) Benefax Disinfectant Spray, Exclusively Sold By Biotek Corporation, Melrose Park, IL; (9) Pheno-Cen Spray Disinfectant/Deodorant, Sold By Central Solutions, Inc., Kansas City, KS; (10) Clark Bio-Phene Plus Disinfectant/Spray, Sold By Clark Paper Plus Inc., Carteret, NJ; (11) LOGIChem Hosp-I-Septic Disinfectant Spray, Distributed Exclusively For Edmar, Woodside, NY; (12) Morcept Hospital Disinfectant, Sold By Moore Research, Inc., St. Louis, MO; (13) Pro Chem Deocept Purity Hospital Disinfectant, Sold By Pro-Chem, Inc., Alpharetta, GA; (14) Select Specialty Products Spectrum II Hospital Type Disinfectant, Sold By Select Specialty Products, Charlottesville, VA.
FDA Recall
Terminated
·ITW Dymon·Product code LRJ·February 15, 2005
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
SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.
FDA Recall
Terminated
·JK Products & Services, Inc·Product code LEJ·July 8, 2005
SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.
FDA Recall
Terminated
·JK Products & Services, Inc·Product code LEJ·July 25, 2014
BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.
FDA Recall
Terminated
·JK Products & Services, Inc·Product code 000·May 7, 2012
BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.
FDA Enforcement
Class II
·Terminated·JK Products & Services, Inc·August 22, 2012
SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.
FDA Enforcement
Class II
·Terminated·JK Products & Services, Inc·September 19, 2012
SUN DASH RADIUS 252 PN 8000809705. The device is intended to be used for the tanning of human skin.
FDA Enforcement
Class II
·Terminated·JK Products & Services, Inc·September 24, 2014
HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt·Product code FKX·December 23, 2002