BEUDAMED
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    ACCU-CHEK Inform meter; catalog No. 3035123.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code NBW·November 19, 2004

    Mammomat Inspiration with Tomosynthesis functionality

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OTE·February 12, 2016

    Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code IXR·October 21, 2004

    Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus that includes the optional Chop / Lift Bar.

    FDA Recall
    Terminated ·BTE Technologies, Inc.·Product code ISD·April 9, 2015

    Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus that includes the optional Chop / Lift Bar.

    FDA Enforcement
    Class II ·Terminated·BTE Technologies, Inc.·July 15, 2015

    Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: 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 Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·June 5, 2019

    GE Healthcare CT/e and HiSpeed X/i, families of computed tomography Systems with Gantry. The CT/e and HiSpeed X/i families CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code JAK·December 1, 2008

    Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Hearing Instruments, Inc·February 26, 2014

    Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients.

    FDA Recall
    Terminated ·Siemens Hearing Instruments, Inc·Product code LEZ·July 1, 2005

    Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.

    FDA Enforcement
    Class II ·Terminated·Technomed Europe·January 19, 2022

    Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.

    FDA Recall
    Terminated ·Technomed Europe Amerikalaan 71 Maastricht-Airport Netherlands·Product code GXZ·December 8, 2021

    Sytec 6000, Sytec 8000, and Lemage/ProSeed/ProSpeed families. The CT/e and HiSpeed X/i families CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code JAK·December 1, 2008

    GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculoskeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (vascular).

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code IYN·September 14, 2018

    Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: 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·April 5, 2019

    Natus neurology Dantec KEYPOINT.NET 2.20. Catalog/Part Numbers: 9031A070103, 9031A006502, 9033A071103, 9033A072102, 9031A070102, 9033A007402, 9033A071102, 9033A072103, 9033A0701, 9033A0711HA, 9033A071101, 9031A070101, 9031A006401, 9031A006501, 9033A004701, 9031A0032, 9033A0517, 9033A072101, 9031A0031, 9031A0701BV, 9033A0044, 9033A0073AA, 9031A0063, 9033A0523, 9033A071143, 9033A072143, 9031A006406, 9031A006506, 9031A070106, 9033A004606 9033A004706, 9033A007406, 9033A0537, 9033A0544, 9033A071106, 9033A072106, 9033A0524, 9033A0711BV, 9033A007401, 9033A0516, 9031A006403, 9031A006503, 9033A056403, 9033A0721BV, 9031A006402, 9031A006405, 9031A051306, 9031A070105, 9033A0072, 9033A007301, 9033A0711AA, 9033A0721AA Product Usage: Dantec KEYPOINT.NET Software 2.20 is installed on the Keypoint EMG System which is intended as an electro-physiological aid to assess diagnosis and prognosis and to monitor diseases of the central and peripheral nervous system. It can also be used to study functional aspects of nerves and muscles.

    FDA Recall
    Terminated ·Alpine Biomed Aps 16-18 Tonsbakken Skovlunde Denmark·Product code GWF·April 9, 2013

    TEE Transducer V5M, when used with the Acuson S2000 Ultrasound System, software versions: VA15, VA15A or VA15B; Model Numbers: 10041461 (Acuson S2000) and 8263703 (V5M Transducer); Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Mountain View, CA Product is a medical device, a multi-purpose mobile, software controlled diagnostic ultrasound system with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. tis function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-mode, MMode, Pulsed(PW) Doppler mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or harmonic imaging and 3d/4d imaging on a flat panel display. The device system is intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The device is a multi frequency, multi plane, phased sector array transducer. In the TEE (transesophageal echocardiography process where the device fails, the transducer is introduced into the esophagus of the patient to obtain images of the heart structure.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYO·April 7, 2009

    Warm Air Model 135 Warming Units.

    FDA Recall
    Terminated ·Cincinnati Sub-Zero Products·Product code BTE·November 5, 2004

    ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)

    FDA Recall
    Terminated ·Bio-Detek, Inc.·Product code DTE·May 28, 2019

    Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. Specific indications for temporary cardiac pacing include, but are not limited to, the following: - Complete heart block - Sinus bradycardia - Sick sinus syndrome - Bradycardia with congestive heart failure - Atrial and/or ventricular arrhythmias - Cardiac arrest - Support, management, and evaluation of a patient before permanent pacemaker implantation - Support during permanent pacemaker replacement - Cardiac complications during invasive or surgical procedures - Support following cardiac surgery - Acute myocardial infarction complicated by heart block - Atrial tachyarrhythmias that require high-rate burst pacing for treatment

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Management·Product code DTE·March 17, 2015

    Oscor PACE 203H, Dual-Chamber External Pulse Generator The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular or A-V sequential pacing. The PACE 203H / Model 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes.

    FDA Recall
    Terminated ·Osypka Medical Inc·Product code DTE·June 30, 2010