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Sources: EU EUDAMED, US FDA
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BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern.
FDA Enforcement
Class II
·Terminated·Becton, Dickinson and Company, BD Biosciences·December 2, 2015
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
Single Chamber Temporary External Pacemaker, Model 53401
FDA Recall
Terminated
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code DTE·June 6, 2018
St. Jude Medical, Model 3085, 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
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
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
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
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
Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601
FDA Recall
Terminated
·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019
Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
FDA Recall
Terminated
·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019
Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178
FDA Recall
Terminated
·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019
Torrent Suite Dx Software Version (IUO) 5.4 Catalog Number: A31774 OEM Customer Software: Sentosa SQ Suite Software v5.6.15
FDA Recall
Terminated
·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019
Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
FDA Enforcement
Class II
·Terminated·Life Technologies Holdings Pte Ltd·October 30, 2019