49 results
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45ms
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Sources: EU EUDAMED, US FDA
Precision Medical- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series, Model number 2201, Precision Medical, Inc., Northampton, PA 18067
FDA Recall
Terminated
·Precision Medical, Inc.·Product code BYJ·October 4, 2006
PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The selector is attached to a flowmeter and is used to direct the outlet flow from any standard flowmeter to any one of the three outlets it provides.
FDA Recall
Terminated
·Precision Medical, Inc.·Product code BTM·March 5, 2010
Easy Go Vac Aspirator, Model PM65HG. Portable suction unit
FDA Recall
Terminated
·Precision Medical, Inc.·Product code BTA·November 9, 2004
Easy Go Vac Aspirator, Model PM65. Portable suction unit
FDA Recall
Terminated
·Precision Medical, Inc.·Product code BTA·November 9, 2004
Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.
FDA Recall
Terminated
·Precision Medical, Inc.·Product code CAN·October 8, 2015
Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators. Varian Medical Systems, Inc. Oncology Systems Intended for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions in the body where radiation treatment is indicated.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·May 26, 2011
CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Recall
Terminated
·Accuray Inc·Product code IYE·October 28, 2010
Optical Guidance Platform, Version 2.6 and 2.6.1, Model Number: HZl, Manufactured and Distributed by: Varian Medical Systems Inc., Palo Alto, CA. For use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·March 30, 2011
Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code FRN·August 22, 2017
CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System radiation therapy device, manufactured by Accuray Inc., Sunnyvale, CA. Medical device indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Recall
Terminated
·Accuray Inc·Product code MUJ·July 6, 2010
Varian brand Clinac and TrueBeam, High Energy Linear Accelerator, Model Numbers: H14, H19, H29; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·March 31, 2011
RoboCouch Patient Support System, a component of the CyberKnife Robotic Radiosurgery System. Model number 025007, manufactured by Accuray Inc., Sunnyvale, CA The CyberKnife is indicated for treatment planning and imageguided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The RoboCouch Patient Support System is intended for use in the support and positioning of a patient during Radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.
FDA Recall
Terminated
·Accuray Inc·Product code JAI·October 30, 2008
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code FRN·August 22, 2017
Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). The device is intended to reduce edema and promote healing of soft-tissue injuries and lymphedema through stimulation of the lymphatic system. The device is a therapeutic system which consists of a control unit and fluid circulating pads. The pads are mounted in wraps designed for specific parts of the body such as ankle, knee, elbow, and shoulder. The pads provide cold treatment and pressure which help promote healing. The owner's manual is labeled in part: "PRO TRAINERS' CHOICE COMPANY, INC.***www.precisionice.com***[email protected]***Mailing Address PO Box 27***Kingston, WA 98346 USA***Phone: 360-297-3902***Shipping Address***26129 Calvary Lane NE, Suite 200***Kingston, WA 98346 USA***Fax: 360-297-3903". The sticker which is placed on the back of the control board is labeled in part: "MOD#4BB02BK***SER#100***". The shipping box is labeled in part: "Pro Trainers' Choice' LLC***Model #4BB02BK***Serial #100____***". The knee wrap is labeled in part: "***Pro Trainers' Choice Co. Inc./Precision Ice One Patient Use Knee Wrap***#1BK01051KN***This device is to be used for one patient only; do not re-use!***".
FDA Recall
Terminated
·Pro Trainers' Choice Company·Product code ILO·April 18, 2011
Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03899; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·March 3, 2011
Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·August 14, 2012
Optical Guidance Platform, version 2.6 and 2.6.1; Reference/FSCA Identifier: CP-03976; Model Number: HZ1; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Optical Guidance Platform is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·March 3, 2011
Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 12722-65. Intended use: for the administration of fluids.
FDA Recall
Terminated
·Hospira Inc.·Product code FPA·July 13, 2012
Clinac Linear Accelerator; Model numbers H14, H27 and H29. Product Usage: Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·May 18, 2011
TrueBeam Linear Accelerators (aka Trilogy Mx) Varian Medical Systems, Palo Alto, CA Product Usage: Intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors , and conditions anywhere in the body where radiation treatment is indicated.
FDA Recall
Terminated
·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·May 19, 2011