60 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Recall
Terminated
·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code MQB·January 7, 2020
Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Recall
Terminated
·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code MQB·January 7, 2020
Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Recall
Terminated
·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code MQB·January 7, 2020
Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Recall
Terminated
·Palodex Group Oy Nahkelantie 160 Tuusula Finland·Product code MQB·January 7, 2020
PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with the following date code; 0639XX through 1253XX (YYWWXX, where YY=Year, and WW=week).
FDA Recall
Terminated
·bioMerieux, Inc.·January 24, 2020
KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Enforcement
Class II
·Terminated·Palodex Group Oy·January 29, 2020
Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Enforcement
Class II
·Terminated·Palodex Group Oy·January 29, 2020
Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Enforcement
Class II
·Terminated·Palodex Group Oy·January 29, 2020
BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·November 7, 2018
Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO 80027. The Polaris Spectra Position Sensor Unit (PSU) is the component of the StealthStation S7 System which detects optical markers on instruments and reference frames, determines their spatial positions, and continuously reports this information to the system computer. The computer uses this spatial information, in conjunction with information regarding the geometry of the instrument currently in use, to determine where the tip of the instrument is located on the patient anatomy.
FDA Recall
Terminated
·Medtronic Navigation, Inc·Product code HAW·December 22, 2010
Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Enforcement
Class II
·Terminated·Palodex Group Oy·January 29, 2020
PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with the following date code; 0639XX through 1253XX (YYWWXX, where YY=Year, and WW=week).
FDA Enforcement
Class II
·Terminated·bioMerieux, Inc.·April 29, 2020
StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.
FDA Recall
Terminated
·Medtronic Navigation, Inc.·Product code HAW·June 5, 2020
StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures.
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.·August 5, 2020
Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
FDA Recall
Terminated
·The Magstim Company Limited Spring Gardens Whitland United Kingdom·Product code OBP·March 23, 2020
Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
FDA Recall
Terminated
·The Magstim Company Limited Spring Gardens Whitland United Kingdom·Product code OBP·March 23, 2020
Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
FDA Enforcement
Class II
·Terminated·The Magstim Company Limited·May 20, 2020
Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
FDA Enforcement
Class II
·Terminated·The Magstim Company Limited·May 20, 2020
Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities.
FDA Enforcement
Class II
·Terminated·Nellcor Puritan Bennett Inc. (dba Covidien LP)·July 2, 2014
Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept the registration and the Table Move Assistant dialog box appears. (3) The Relative Actual column of the Table Move Assistant dialog box incorrectly appears blank. (4) When this occurs, XVI does not read the Absolute Actual position of the treatment table. This causes XVI to calculate the treatment table moves from the zero position of the treatment table (+0.0, + 0.0, + 0.0). (5) In XVI R5.0, if the Relative Set values are less than or equal to + or -2.5cm (for earlier releases of XVI, the value is + or -2cm), you can do remote automatic table movement (RATM) from the function keypad (FKP). (6) When you press the Table ASU (automatic setup) buttons, the treatment table moves to a position that was incorrectly calculated from XVI.
FDA Recall
Terminated
·Elekta, Inc.·Product code IYE·November 25, 2013