349 results
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54ms
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Sources: EU EUDAMED, US FDA
SAFE PLACE
FDA Adverse Event
Malfunction
·RF TECHNOLOGIES, INC·Product code KMI·April 16, 2020
Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.
FDA Enforcement
Class II
·Terminated·RF Technologies, Inc.·July 3, 2013
Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.
FDA Recall
Terminated
·RF Technologies, Inc.·Product code KMI·May 17, 2013
CODE ALERT
FDA Adverse Event
Death
·RF TECHNOLOGIES, INC.·Product code KMI·March 15, 2002
CODE ALERT
FDA Adverse Event
Other
·RF TECHNOLOGIES, INC·Product code KMI·October 23, 2003
CODE ALERT
FDA Adverse Event
Malfunction
·RF TECHNOLOGIES, INC.·Product code KMI·May 19, 2005
SENSATEC
FDA Adverse Event
Death
·RF TECHNOLOGIES, INC·Product code KMI·February 7, 2007
CODE ALERT
FDA Adverse Event
Malfunction
·RF TECHNOLOGIES, INC.·Product code KMI·December 30, 1996
SAFE PLACE
FDA Adverse Event
Malfunction
·RF TECHNOLOGIES, INC·Product code KMI·July 6, 2022
SAFEPLACE INFANT SECURITY BAND
FDA Adverse Event
Other
·RF TECHNOLOGIES, INC.·Product code KMI·February 14, 2005
SAFE PLACE PATIENT WANDERING
FDA Adverse Event
Injury
·RF TECHNOLOGIES, INC·Product code KMI·July 9, 2007
SAFE PLACE
FDA Adverse Event
Malfunction
·RF TECHNOLOGIES, INC·Product code KMI·November 16, 2011
SAFE PLACE INFANT SECURITY
FDA Adverse Event
Malfunction
·RF TECHNOLOGIES, INC·Product code KMI·November 16, 2011
WONDERGUARD
FDA Adverse Event
Death
·RF TECHNOLOGIES, INC·Product code KMI·October 22, 2002
TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code OAE·March 6, 2025
QDOT MICRO
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code OAE·March 19, 2025
VARIPULSE¿ BI-DIRECTIONAL CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code QZI·March 19, 2025
OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code DRF·August 4, 2025
Bed/chair alarm
FDA Recall
Terminated
·RF Technologies, Inc.·Product code KMI·December 16, 2002
CODE ALERT - SENSATEC
FDA Adverse Event
Malfunction
·R F TECHNOLOGY, INC.·Product code KMI·January 12, 1999