22 results
·
45ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
LINET AMERICAS
FDA Adverse Event
Death
·LINETAMERICAS·Product code FNL·November 20, 2017
LINET AMERICAS BED
FDA Adverse Event
Injury
·LINET SPOL. S R.O.·Product code FNL·April 4, 2022
PRESSURE GUARD
FDA Adverse Event
Malfunction
·SPAN-AMERICA MEDICAL SYSTEMS, INC.·Product code FNM·January 31, 2025
PROTEVO APC
FDA Adverse Event
Malfunction
·LINET AMERICAS INC.·Product code FNM·January 31, 2025
ACCUMAX QUANTUM VPC PRS
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code IKY·January 31, 2025
ISOLIBRIUM
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code IKZ·January 31, 2025
MULTCARE
FDA Adverse Event
Malfunction
·LINET SPOL. S R.O.·Product code FNL·July 22, 2022
MULTICARE
FDA Adverse Event
Malfunction
·LINET AMERICAS·Product code INY·October 25, 2016
SYMBIOSO INTEGRATED LOW AIR LOSS MATTRESS
FDA Adverse Event
Malfunction
·LINET AMERICAS·Product code FNM·May 29, 2014
LINET
FDA Adverse Event
Malfunction
·LINET AMERICAS·Product code FNL·December 1, 2017
LINET
FDA Adverse Event
Malfunction
·LINET AMERICAS·Product code FNL·March 28, 2023
LINET
FDA Adverse Event
Malfunction
·LINET AMERICAS·Product code FNL·August 4, 2021
ELEGANZA
FDA Adverse Event
Malfunction
·LINET AMERICAS·Product code FNL·December 31, 2012
Eleganza 3 Hospital Bed Intended use: AC Powered adjustable Hospital Bed
FDA Recall
Terminated
·Linet Americas Inc·Product code FNK·May 2, 2011
MULTICARE LE
FDA Adverse Event
Malfunction
·LINET AMERICAS INC.·Product code FNL·February 3, 2016
LINETAMERICAS MULTICARE BED
FDA Adverse Event
Injury
·LINET·Product code FNL·July 26, 2017
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·September 2, 2025
AG-920RA
FDA Adverse Event
Malfunction
·Product code CCK·November 8, 2019
AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed.
FDA Recall
Open, Classified
·Linet Americas·Product code HDD·March 6, 2020
AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed.
FDA Enforcement
Class III
·Ongoing·Linet Americas·August 19, 2020