454 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Aplio 80; SSA-770A; software version 5.5r002
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code IYN·November 12, 2007
Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code IYN·August 5, 2013
Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code IYN·August 5, 2013
Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·April 2, 2014
ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system. Siemens Medical Solutions USA, Inc., Mountain View, CA
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·September 25, 2007
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
ACUSON Antares 5.0 ultrasound system at SW revision 200.0.054 or 200.0.059A, with one of the following options installed: 3-Scape Imaging, Factory, PN 05937011 or 3-Scape Real Time Imaging, UPG ACU, PN 10033688. Material number 10032746, 10037592, 10032746, 10037591 or 10038202.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·March 21, 2008
Software for SSH-880CV Aplio Artida; System Diagnostic Ultrasound
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code IYN·January 6, 2010
Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·March 1, 2010
ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·October 7, 2015
Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0)
FDA Recall
Terminated
·Philips Ultrasound, Inc.·Product code IYN·December 9, 2015
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.
FDA Recall
Terminated
·Butterfly Network, Inc.·Product code IYN·February 24, 2020
Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live Echo Guidance.
FDA Recall
Terminated
·Philips Ultrasound Inc·Product code IYN·December 24, 2020
Toshiba Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1 software, Toshiba America Medical Systems, Inc., Tustin, CA. 92780
FDA Recall
Terminated
·Toshiba American Med Sys Inc·Product code IYN·October 2, 2007
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
HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).
FDA Recall
Terminated
·Philips Ultrasound, Inc.·Product code IYN·September 10, 2004
Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02, manufactured by Siemens Ultrasound
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·August 19, 2008
Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·March 7, 2014
APLIO 500 TUS-A500 diagnostic ultrasound system
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code IYN·May 1, 2017
Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D
FDA Recall
Terminated
·GE Healthcare, LLC·Product code IYN·July 2, 2019