94 results
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15ms
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Sources: EU EUDAMED, US FDA
Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code FMT·September 25, 2018
AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code OAB·April 24, 2020
ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603 Queensbury Ave., Queensbury, NY 12804 Intended to remove tissue and control bleeding by the use of high- frequency electrical current (surgical ablation of soft tissue).
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code OAB·April 4, 2011
Panda iRes and Giraffe Infant Warmers, labeled in part*** GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com*** Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.
FDA Recall
Terminated
·Datex Ohmeda, Inc. dba GE Healthcare·Product code FMT·May 20, 2008
Panda iRes Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com** Panda Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.
FDA Recall
Terminated
·GE Healthcare·Product code FMT·December 12, 2013
Panda iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
FDA Recall
Terminated
·GE Healthcare·Product code FMT·April 2, 2014
GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code BTL·October 1, 2013
GE Healthcare - Giraffe and Panda iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonates transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code BTL·October 1, 2013
Alinity ci -series System ControlModule, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry module and an immunoassay module, each performing all sample processing activities, and a system control module to provide a single user friendly interface. Each system can be customized by combining one or more sample processing modules, in multiple configurations, with a system control module to form a single workstation. The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
FDA Recall
Terminated
·Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany·Product code JJE·June 10, 2019
LAMINECTOMY PACK - ( I) RING BASIN LIF (2) TABLE COVER REINFORCED 50" X 90" LIF ( I) SKIN MARKER INK W/8 LABEL ( I) CAUTERY TIP POLISHER LIF ( I) TUBE SUCTION CONNECT. W' X 12' LIF (6) DRAPE UTILITY W/TAPE LIF (I 0) GAUZE SPONGE 4" X 4" 16PL Y LIF (2) UTILITY BOWL 16oz. LIF ( IO) LAP SPONGE PRE-WASH XRD LIF (2) SPECIMEN CONTAINER 4oz W/LID & LABEL (2) MAYO STAND COVER REINFORCED LIF ( I) GOWN SURG. REINF. XL TOWEL WRAP (6) ABSORBENT TOWEL I5" X 20" LIF ( I) DRAPE LAP 102" X 121" X 78" W/POUCI-1 SMS LIF ( I) SURGICAL DURAPREP SOLUTION 26ML LIF (6) DRAPE SHEET 41" X 69" MEDIUM LIF (2) LEGGING W/7'' CUFF 30" X 42" LIF (2) NEEDLE & BLADE COUNTER I Oc MAG /CLEAR ( I) CAUTERY PENCIL PUSH BOTTOM LIF ( I) BAG SUTURE FLORAL LIF ( I) PVP SCRUB 8" STICK SPONGE ( I) MAYO TRAY LARGE LIF (I 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF ( I) SURGICAL BLADE# I 0 CARBON STEEL (2) BULB SYRINGE 60cc CLEAR LIF ( I) SURGICAL BLADE# I I CARBON STEEL ( I) SURGICAL BLADE # 15 CARBON STEEL ( I) GOWN FABRIC REINFORCED SONTARA XL LIF ( I) SYRINGE IOcc W/NDL 20G X I Y, LILOCK LIF ( I) PVP PAINT 8" STICK SPONGE ( I) SURGICAL STRIP W' X 6" COTTON (2) LITE GLOVES LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014
Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code FMT·March 15, 2019
Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code FMT·March 15, 2019
RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
FDA Recall
Terminated
·Siemens Healthcare Diagnostics Inc·Product code CHL·May 27, 2020
Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
FDA Recall
Terminated
·Clarity Medical Systems Inc·Product code HKI·March 7, 2014
Retcam3 & Retcam Shuttle with version 6.0 software. Clarity Medical Systems, Inc. 5775 W. Las Positas Blvd, Suite 200 Pleasanton, CA 94588 General ophthalmic imaging including retinal, corneal and external imaging. Photodocumentation of pediatric ocular diseases including retinopathy or prematurity (ROP). Screening of Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
FDA Recall
Terminated
·Clarity Medical Systems Inc·Product code HKI·February 2, 2012
SYNCHRON Systems Calibrator 1, Part Numbers: 468405, Lots prior to M005558 The Beckman Coulter SYNCHRON Calibrator 1 (CAL 1), used in conjunction with SYNCHRON reagents, is intended for the calibration of immunoprotein tests on SYNCHRON LX and UniCel DxC Systems.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code JIT·March 11, 2011
EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet, iM70 Vet Monitors, and is intended to be used to measuring expired CO2 as part of multi parameter patient monitors. The Patient Monitors are intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates, such as ECG, Respiration (RESP), IBP, NIBP, Cardiac Output (C.O.), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG).
FDA Recall
Terminated
·Edan Diagnostics·Product code MHX·June 23, 2016
Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.
FDA Recall
Terminated
·Bausch & Lomb Inc Irb·Product code HNN·July 11, 2016
LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.85 (6/BOX), REF/PRODUCT CODE E7528, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
FDA Recall
Terminated
·Bausch & Lomb Inc Irb·Product code HNN·March 3, 2017
LASEREDGE Knives, 22.5 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7522, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
FDA Recall
Terminated
·Bausch & Lomb Inc Irb·Product code HNN·March 3, 2017