35 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular.
FDA Recall
Terminated
·Vascular Technology, Inc.·Product code DPW·June 19, 2018
Nicolet Elite 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
FDA Recall
Terminated
·Natus Neurology Inc·Product code JAF·June 9, 2017
Nicolet Elite 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
FDA Recall
Terminated
·Natus Neurology Inc·Product code JAF·June 9, 2017
Nicolet Elite 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
FDA Recall
Terminated
·Natus Neurology Inc·Product code JAF·June 9, 2017
Nicolet Elite 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
FDA Recall
Terminated
·Natus Neurology Inc·Product code JAF·June 9, 2017
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
Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code ITX·January 6, 2014
Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for determining fetal viability.
FDA Recall
Terminated
·CooperSurgical, Inc.·Product code KNG·October 6, 2017
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.
FDA Recall
Open, Classified
·Koven Technology, Inc.·Product code DPW·March 4, 2026
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
MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer
FDA Recall
Terminated
·Sonosite, Inc.·Product code IYN·February 5, 2007
Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3
FDA Recall
Open, Classified
·Securitas Healthcare LLC·Product code IQA·December 8, 2025
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
FDA Recall
Open, Classified
·Securitas Healthcare LLC·Product code IQA·December 8, 2025
Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00
FDA Recall
Terminated
·Welch Allyn Protocol, Inc·Product code DSI·December 31, 2003
XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT QUICK CONNECT USB, 41000-030-53; e) XSCRIBE CP KIT WIRELESS, 41000-030-60; f) XSCRIBE CP KIT WIRED, 41000-030-62; g) XSCRIBE CP SW KIT, 41000-030-64
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code DPS·December 8, 2023
SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.
FDA Recall
Terminated
·Aesthetics Biomedical, Inc.·Product code OUH·March 13, 2020
Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Model 91341-09 transmitter, 90478-1CST receiver and 90478-1CSV receiver.
FDA Recall
Terminated
·Spacelabs Medical Incorporated·Product code DSI·May 5, 2006
Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcranial Doppler Ultrasound System & PMD 100 Digital Transcranial Doppler Ultrasound System (these systems are the same hardware and software - the change from TCD 100M to PMD 100 is a marketing change). Software version 1.3.0 Model numbers 10119, 10863, 10919, 10968, 11016, 11052, 11090, 11091, 11235, 11236
FDA Recall
Terminated
·Spencer Technologies, Inc.·Product code IYN·February 19, 2004
Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code MHZ·August 31, 2018
The 91220 mCare 300 Vital Signs monitor has a 10.4 inch resistive touchscreen display. The Spacelabs Medical, mCare 300, Model 91220, Vital Signs Monitor is a compact monitoring system with a resistive touchscreen display. It is indicated for use in adult, pediatric and neonate patient populations wherever there is a need for the monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire CO2. The product is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
FDA Recall
Terminated
·Spacelabs Healthcare, Incorporated·Product code MHZ·April 14, 2010