15 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA.
FDA Enforcement
Class II
·Terminated·CIVCO Medical Instruments Co., Inc.·December 19, 2018
SonoSite L25 Needle Guide Kit, 21 GAUGE, Part Number P04053-01. Manufactured for: SonoSite, Inc., Bothell, WA 98021 Each kit is packaged in a hermetically sealed clear plastic pouch with white backing. Product is labeled as Sterile. 24 pouches are packaged in a white cardboard box and labeled as SonoSite L25 Needle Guide Kit, 21 GAUGE REF# P04053-01, Quantity: 24, CONTENTS STERILE IF PACKAGE IS INTACT. Mfg for: Sonosite, Inc. 888/482-9449*425/951-1200, Bothell, WA 98021 USA. www.sonosite.com
FDA Recall
Terminated
·Sonosite, Inc.·Product code ITX·December 12, 2005
SLT transducer is used on the SonoSite MicroMaxx ultrasound system. The SLT Transducer label is labeled in part: " MicroMaxx SLT...Manufactured for SonoSite, Inc., Bothell, WA 98021".
FDA Recall
Terminated
·Sonosite, Inc.·Product code IYN·November 2, 2007
Laparoscopic Ultrasound Transducer (LAP Transducer) is used on the SonoSite MicroMaxx ultrasound system. The LAP Transducer label is labeled in part: "MicroMaxx LAP...Manufactured for SonoSite, Inc., Bothell, WA 98021".
FDA Recall
Terminated
·Sonosite, Inc.·Product code IYN·November 2, 2007
CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.
FDA Enforcement
Class II
·Terminated·CIVCO Medical Instruments Co., Inc.·December 19, 2018
SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA.
FDA Recall
Terminated
·CIVCO Medical Instruments Co., Inc.·Product code ITX·November 2, 2018
SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer... SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021". The TEE/8-3 MHz Transducer is designed for 2D, M Mode, color Doppler, pulse wave (PW) Doppler and continuous wave (CW) Doppler by applying ultrasound energy through the esophagus or stomach of the patient into the heart. The TEE transducer is intended to be used on adults only. Backscattered ultrasound energy from the patient's heart is used to form images of the heart to detect abnormalities in structure or motion, to evaluate the velocity of blood flowing within the heart, and to obtain a color depiction of the velocities of blood flowing in the heart.
FDA Recall
Terminated
·Sonosite, Inc.·Product code IYO·August 8, 2008
P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
FDA Enforcement
Class II
·Terminated·SonoSite, Inc.·October 23, 2013
MicroMaxx ultrasound system and M-Turbo ultrasound system is Medical Diagnostic Ultrasound. General purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body.
FDA Recall
Terminated
·Sonosite, Inc.·Product code IYN·July 18, 2011
P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
FDA Recall
Terminated
·SonoSite, Inc.·Product code IYO·September 11, 2013
CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx.
FDA Recall
Terminated
·CIVCO Medical Instruments Co., Inc.·Product code ITX·November 2, 2018
The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5). The software is used with the SonoSite NanoMaxx ultrasound system.
FDA Recall
Terminated
·Sonosite, Inc.·Product code IYN·August 13, 2010
SonoCalc IMT 3.0, a windows based software used in conjunction with images from high-resolution ultrasound systems (MicroMaxx, TITAN, and SonoSite180PLUS). This software generates a report with the patients intima media thickness (IMT) based on average thickness of the carotid artery.
FDA Recall
Terminated
·Sonosite, Inc.·Product code LLZ·October 26, 2005
MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer
FDA Recall
Terminated
·Sonosite, Inc.·Product code IYN·February 5, 2007
PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the stand mounted assembly (P12822) and a docking assembly (P12834). The stand mounted assembly is mounted to the V or H Universal stand and the docking assembly is plugged into a wall circuit. It provides a docking and charging station for the V and H Universal Stands. The product marketing brochure labeled in part: "SonoSite Ltd...21919 30th Drive SE... Bothell, WA 98021, USA".
FDA Recall
Terminated
·Sonosite, Inc.·Product code IYN·May 27, 2010