701 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
FDA Enforcement
Class II
·Terminated·Welch Allyn Inc Mortara·April 28, 2021
LIFEPAK 20 automatic external defibrillator
FDA Recall
Terminated
·Medtronic Emergency Response Systems, Inc.·Product code LDD·March 16, 2006
Pediatric Paddles attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK 20/20e Defibrillator/Monitors.
FDA Recall
Terminated
·Physio Control, Inc.·Product code LDD·November 17, 2008
standard (hard) paddles used with the LIFEPAK 12 defibrillator/monitor series.
FDA Recall
Terminated
·Medtronic Emergency Response Systems, Inc.·Product code LDD·September 2, 2005
Physio-Control LIFEPAK 20e defibrillator/monitor, sold internationally only, is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.
FDA Recall
Terminated
·Physio Control, Inc.·Product code LDD·April 16, 2008
QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series.
FDA Recall
Terminated
·Medtronic Emergency Response Systems, Inc.·Product code LDD·September 2, 2005
External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor.
FDA Recall
Terminated
·Physio Control, Inc.·Product code LDD·November 17, 2008
Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external defibrillator sold internationally only
FDA Recall
Terminated
·Physio Control, Inc.·Product code LDD·May 13, 2008
LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction defibrillator pads to be used with the HeartStart 3000 and 4000 series defibrillators and Philips Medical Systems CodeMaster 100 and XL series defibrillators. The Adapter Cable is supplied to customers as an independent accessory and is sold in a clear poly bag with a white stick on label that reads ''PART # 920650 ADAPTER CM100 / LMC ELECTRODE''. There is no other labeling and no directions for use that accompany the product. The Adapter Cable is also included as a component of the CodeMaster 100 Accessory Pack.
FDA Recall
Terminated
·Laerdal Medical Corporation·Product code LDD·April 29, 2005
R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721, NON-STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13505. This device, when connected to a monitor/defibrillator has the ability to monitor the electro-cardio function (ECG) of the patient. The device, when electrically activated by the monitor/defibrillator can pace the heart rate of the patient and may also transmit the electrical current to the patient for cardio-conversion. This is a non-sterile, disposable device.
FDA Recall
Terminated
·ConMed Corporation·Product code LDD·March 9, 2011
The LIFEPAK 20 defibrillator/monitor is an AC powered external defibrillator with battery backup used by healthcare providers in hospital and clinic settings. Affected Product Part Numbers: 3202487-000 thru -012, 3202487-014 thru -027, 3203487-029 thru -039, 3202488-000 thru -019, U3202487-000, U3202487-015, U3202488-000.
FDA Recall
Terminated
·Physio Control, Inc.·Product code LDD·December 30, 2008
Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft).
FDA Recall
Terminated
·Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom·Product code LDD·November 17, 2020
Physio-Control LIFEPAK 12 defibrillator/monitor is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.
FDA Recall
Terminated
·Physio Control, Inc.·Product code LDD·April 16, 2008
Physio-Control LIFEPAK 20 defibrillator/monitor. This product is an external defibrillator sold internationally and domestically.
FDA Recall
Terminated
·Physio Control, Inc.·Product code LDD·May 13, 2008
DC Power Adapter for use with the LIFEPAK 12 defibrillator/monitor.
FDA Recall
Terminated
·Medtronic Physio Control Corp·Product code LDD·May 5, 2004
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
FDA Recall
Terminated
·Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom·Product code LDD·January 28, 2022
LIFEPAK 12 defibrillator/monitor.
FDA Recall
Terminated
·Medtronic Physio Control Corp·Product code LDD·April 5, 2004
LIFEPAK 20 defbrillator/monitor
FDA Recall
Terminated
·Medtronic Emergency Response Systems, Inc.·Product code LDD·June 17, 2005
LIFEPAK 20 external defibrillator/monitor
FDA Recall
Terminated
·Medtronic Emergency Response Systems, Inc.·Product code LDD·August 30, 2006
LIFEPAK 20 defibrillator/monitor
FDA Recall
Terminated
·Medtronic Emergency Response Systems, Inc.·Product code LDD·March 22, 2006