42 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
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
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
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
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
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 Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT
FDA Recall
Terminated
·Cti Pet Systems Inc·Product code KPS·October 2, 2003
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
Laser Meter, Model No. LTM80, K-TEK, Prairieville, LA 70769
FDA Recall
Terminated
·K Tek·Product code K--DD·November 3, 2006
Laser Distance and Level Transmitters, Model No. LT4C, ASI, 8570 Katy Freeway, Suite 117, Houston, TX 77024
FDA Recall
Terminated
·K Tek·Product code K--DD·November 3, 2006
LaserTrak, Model No. LT80, ASI, Houston, TX 77024
FDA Recall
Terminated
·K Tek·Product code K--DD·November 3, 2006
Laser Distance and Level Transmitters, Model No. LM02, K-Teck, 18321 Swamp road, Prairieville, LA 70769
FDA Recall
Terminated
·K Tek·Product code K--DD·November 3, 2006
Laser Distance and Level Transmitters, Model No. LM200, K-Tek, Prairieville, LA 70769
FDA Recall
Terminated
·K Tek·Product code K--DD·November 3, 2006
Laser Level Transmitters, Model No. LM4C, K-TEK, 18321 Swamp Road, Prairieville, LA 70769
FDA Recall
Terminated
·K Tek·Product code K--DD·November 3, 2006
Laser Distance and Level Transmitters, Model No. LT200, ASI, Housotn, TX 77024
FDA Recall
Terminated
·K Tek·Product code K--DD·November 3, 2006
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