187 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, BD Biosciences, San Jose, CA 95131.
FDA Recall
Terminated
·BD Biosciences·Product code GKZ·September 6, 2007
SMV DSX New Line, System, Tomography, Computed, Emission
FDA Recall
Open, Classified
·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code IYX·December 10, 2025
Dynex DSX Software-IVD ELISA Assays effected as follows: DSX Assay File Software: ZEUS vl B. burgdorferi lgG-lgM.asy ZEUS vl Borrelia VlsEl-pepClO lgG-lgM.asy ZEUS Parvovirus B19 lgG (9Z7701G).asy ZEUS Parvovirus B19 lgM (9Z7701M).asy ZEUS vl HSV-1 and 2 lgM.asy ZEUS vl Sm-RNP [CF] .asy ZEUS vl Sm-RNP [CV].asy ZEUS vl CMV lgG.asy ZEUS vl CMV lgM.asy ZEUS vl EBV-VCA lgG.asy ZEUS vl EBV-VCA lgM.asy ZEUS vl H. pylori lgG.asy ZEUS vl M. pneumoniae lgG.asy ZEUS vl M. pneumoniae lgM.asy ZEUS vl Measles lgG.asy ZEUS vl Mumps lgG .asy ZEUS vl T. gondii lgG .asy ZEUS vl T. gondii lgM.asy ZEUS vl VZV lgG.asy ZEUS vl Rubella lgG .asy ZEUS vl Rubella lgM.asy ZEUS vl MPO [CF].asy ZEUS vl MPO [CV].asy ZEUS vl EBNA-1 lgG.asy ZEUS vl.1 HSV-1 and 2 lgM.asy Product Usage: The DYNEX DSX Automated ELISA System is an open automated open system to perform ELISA immunoassay
FDA Recall
Terminated
·Zeus Scientific, Inc.·Product code N/A·July 22, 2019
Pipette Sample Tip, Product part #65910, packaged in cardboard cartons containing 4 plastic racks of 108 pipette tips per rack. Pipette tips are accessory component for Dynex Technologies proprietary automated DSX system.
FDA Recall
Terminated
·Dynex Technologies, Inc.·Product code JQW·June 11, 2004
Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
FDA Recall
Terminated
·Mizuho OSI·Product code JEA·December 17, 2012
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
FDA Recall
Open, Classified
·Mizuho OSI·Product code LXH·July 29, 2021
216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.
FDA Recall
Terminated
·Mizuho OSI·Product code FWZ·March 28, 2017
Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.
FDA Recall
Terminated
·Mizuho OSI·Product code GDC·December 14, 2015
Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.
FDA Recall
Terminated
·Mizuho OSI·Product code JEA·October 14, 2019
Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand control Unit - Product Usage: intended to support a patient during surgical operations.
FDA Recall
Open, Classified
·Mizuho OSI·Product code GDC·February 8, 2021
Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery.
FDA Recall
Terminated
·Berchtold Corp.·Product code LWG·April 19, 2016
Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for X-ray systems. Usage: Ceiling suspension unit with an actuator to hold monitors and X-ray shields.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IZI·June 26, 2008
Artis zee biplane, Model Number 10094141
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
Artis zee floor MN, Model Number 10094142
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
Artis zee ceiling, Model Number 10094137
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
AXIOM Artis dFC, Model Number 7412807
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
AXIOM Artis dTC, Model Number 7413078
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
AXIOM Artis BC, Model Number 5904649
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
AXIOM Artis TC, Model Number 7728350
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
AXIOM Artis dFC, Model Number 7727717
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019