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    Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor

    FDA Recall
    Open, Classified ·SUREPULSE MEDICAL LTD Medicity D6 Thane Road Nottingham United Kingdom·Product code DQA·January 20, 2023

    Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor

    FDA Recall
    Open, Classified ·SUREPULSE MEDICAL LTD Medicity D6 Thane Road Nottingham United Kingdom·Product code DQA·January 20, 2023

    Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor

    FDA Recall
    Open, Classified ·SUREPULSE MEDICAL LTD Medicity D6 Thane Road Nottingham United Kingdom·Product code DQA·January 20, 2023

    Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor

    FDA Recall
    Open, Classified ·SUREPULSE MEDICAL LTD Medicity D6 Thane Road Nottingham United Kingdom·Product code DQA·January 20, 2023

    Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor

    FDA Recall
    Open, Classified ·SUREPULSE MEDICAL LTD Medicity D6 Thane Road Nottingham United Kingdom·Product code DQA·January 20, 2023

    Dimension(R) Vista(R) V-LYTE(R) Diluent (K835) Product Usage: V-LYTE(R) Diluent is for the automatic dilution of samples processed in the V-LYTE(R) Integrated Multisensor on the Dimension Vista(R) system

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·October 31, 2011

    Dimension(R) Vista(R) V-LYTE(R) Standard A (K820) Product Usage: V-LYTE(R) Standard A is for the calibration of NA, K, and CL on the Dimension Vista(R) system

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·October 31, 2011

    Dimension(R) Vista(R) V-LYTE(R) Standard B/Salt Bridge (K825) Product Usage: V-LYTE(R) Standard B/Salt Bridge is for the calibration and measurement of NA, K, and CL on the Dimension Vista(R) system

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·October 31, 2011

    SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).

    FDA Recall
    Terminated ·Sentec AG Ringstrasse 39 Therwil, Baselland Switzerland·Product code LKD·July 9, 2012

    Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. The SenTec Digital Monitoring System (SDMS) is used for continuous and non-invasive monitoring of transcutaneous carbon dioxide tension (tcPCO2), oxygen saturation (SpO2), and pulse rate (PR).

    FDA Recall
    Terminated ·SenTec AG Ringstrasse·Product code LKD·March 25, 2015

    The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated Nanosphere Verigene System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the following pathogenic bacteria: - Campylobacter Group (comprised of C. coli, C. jejuni, and C. lari), - Salmonella species, - Shigella species (including S. dysenteriae, S. boydii, S. sonnei, and S. flexneri), - Vibrio Group (comprised of V. cholerae and V. parahaemolyticus), - Yersinia enterocolitica. In addition, EP detects the Shiga toxin 1 gene and Shiga toxin 2 gene virulence markers. Shiga toxin producing E. coli (STEC) typically harbor one or both genes that encode for Shiga Toxins 1 and 2. EP is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological information; however, is not to be used to monitor these infections. EP also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. Due to the limited number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Yersinia enterocolitica, Vibrio Group and Shigella species were primarily established with contrived specimens. Concomitant culture is necessary for organism recovery and further typing of bacterial agents. EP results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative EP results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

    FDA Recall
    Terminated ·Nanosphere, Inc.·Product code PCH·October 10, 2013

    Implantable Cardioverter Defibrilators Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-196T/V-350) Atlas DR (V242), and Atlas Plus DR/VR/HF (V-243/V-193C/V-340/V-341/V-343).

    FDA Recall
    Terminated ·Product code NIK·June 17, 2005

    Siemens Medical Solutions E.CAM Patient Handling System (PHS) Field of View (FOV) indicator bars; a component of the E.CAM Emission Computed Tomography System; part number 43 66 618 (right) and 43 81 088 (left).

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·December 18, 2008

    Life Pulse High Frequency Ventilator (HFV)

    FDA Recall
    Terminated ·Bunnell, Inc.·Product code LSZ·April 4, 2005

    MIM software; System, Image Processing, Radiological

    FDA Recall
    Open, Classified ·MIM Software Inc·Product code LLZ·February 19, 2025

    Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code KPS·April 25, 2016

    Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·April 25, 2016

    Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·April 25, 2016

    Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·April 25, 2016

    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.

    FDA Recall
    Terminated ·NEUSOFT MEDICAL SYSTEMS IMP &·Product code JAK·January 9, 2019