12 results
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39ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM Artis FA 05904441; AXIOM Artis MP 05904466; AXIOM Artis BC 05904649; AXIOM Artis BA 05904656; AXIOM Artis dBC Mag. Nav. 05917054; AXIOM Artis TA 07007755; AXIOM Artis dTA 07008605; AXIOM Artis dFC 07412807; AXIOM Artis dTC 07413078; AXIOM Artis dBA 07555357; AXIOM Artis dMP 07555365; AXIOM Artis dFA 07555373; AXIOM Artis dFC Mag. Nav. 07727717; AXIOM Artis TC 07728350; AXIOM Artis dBC 07728392; Artis zee floor 10094135; Artis zee ceiling 10094137; Artis zee MP 10094139; Artis zee biplane 10094141; Artis zee floor MN 10094142; Artis zee biplane MN 10094143; Artis Q floor 10848280; Artis Q ceiling 10848281; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen ceiling 10848354; Artis Q.zen biplane 10848355.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·March 30, 2021
Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malvern, PA 19355. Intended for x-ray, angiographic use.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MQB·April 12, 2010
AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS System, X-Ray, Fluoroscopic, image-intensified; solid state x-ray imager (flat panel/digital imager)
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MQB·January 14, 2011
Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1). Component used to determine composition of urinary calculi, urinary sediments, bio-crystallates and diagnosis of pathological characteristics in medical applications (e.g.: testing for gout or pseudogout); also used for non-medical scientific research.
FDA Recall
Terminated
·Zeiss, Carl Inc·Product code IBJ·December 20, 2013
Axiom Artis Zee. Angiographic X-ray System.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZI·August 22, 2008
AXIOM Sireskop SX Model numbers 3111676 and 3111668. The product is intended for use as radiographic and fluoroscopic imaging device.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code JAA·January 8, 2009
AXIOM Sireskop SD Model numbers 8890415 and 8890407. The product is intended for use as radiographic and fluoroscopic imaging device.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MQB·January 8, 2009
AXIOM Artis. Angiographic X-ray System.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZI·August 22, 2008
Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 6, 2017
XiO Radiation Treatment Planning System, XiO Release 4.0.0 through 4.40.00 Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
FDA Recall
Terminated
·Computerized Medical Systems Inc·Product code MUJ·April 8, 2008
XiO Radiation Treatment Planning System, XiO Release 4.3.1 through 4.40.00. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.
FDA Recall
Terminated
·Computerized Medical Systems Inc·Product code MUJ·December 9, 2008
DirectFRAP (Direct Flourescence Recovery After Photobleaching) Imaging System is an extension unit for Axio Observer that is used for microscopic analyses of dynamic processes within living cells. The DirectFRAP module is a component used in conjunction with Laser Scanning Microscopes, Non-Medical Devices for Research Use. The DirectFRAP Imaging System is a Class 3B laser system. The DirectFRAP Imaging System is a laser manipulation slider which allows coupling of laser light simultaneously with the conventional fluorescence illumination into the reflected-light beam path of the microscope system. Depending on the application, the laser light is used for the targeted bleaching of fluorophores for FRAP experiments or for the conversion of fluorophores within the cell.
FDA Recall
Terminated
·Zeiss, Carl Inc·Product code REK·April 28, 2011