Hill-Rom, Inc.

FDA Regulatory Profile

Summary

Total Recalls
37 (1 Class I)
510(k) Clearances
36
Inspections
13
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0783-2022Class II(1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail January 14, 2022
Z-0640-2022Class IILiko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015December 23, 2021
Z-0639-2022Class IILiko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010December 23, 2021
Z-0402-2022Class IIThese are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 October 14, 2021
Z-2599-2021Class IIStretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily August 11, 2021
Z-2598-2021Class IIFlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjuAugust 11, 2021
Z-2600-2021Class IILikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily August 11, 2021
Z-2597-2021Class IIOctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjusAugust 11, 2021
Z-2601-2021Class IILikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (oAugust 11, 2021
Z-2156-2021Class IIAffinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, DMay 28, 2021
Z-0925-2021Class ILiko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in December 18, 2020
Z-2737-2020Class IIProgressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary June 30, 2020
Z-2738-2020Class IICentrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or prevent pulJune 30, 2020
Z-2246-2020Class IICentrella Smart+ Bed, Catalog Number P7900April 30, 2020
Z-1554-2020Class IINaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient SFebruary 14, 2020
Z-1319-2018Class IIProgressa Bed - AC-powered adjustable hospital bedJanuary 12, 2018
Z-1816-2017Class IITotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position MonitoriFebruary 23, 2017
Z-0326-2017Class IIProduct Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: MAugust 9, 2016
Z-2750-2016Class IIAffinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a July 15, 2016
Z-2376-2016Class IIVolker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable June 14, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and RespirationMarch 4, 2021
K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom VitalsMay 7, 2018
K143414Hill-Rom Wireless Connectivity ModuleMarch 10, 2015
K122473TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2June 3, 2013
K112502PROCEDURAL STRECHER WITH INTELLIDRIVE P8000September 19, 2011
K013709HILL-ROM PRIMAVIEW MONITOR SYSTEMNovember 16, 2001
K973705CONTOR TABLE SURFACEAugust 7, 1998
K981081BRIGHTSTARApril 29, 1998
K972111RUMORS DYNAMIC AIR THERAPY UNITFebruary 2, 1998
K971366INCUWARMERJanuary 5, 1998
K970636TOTALCARE., MODULAR THERAPY SYSTEM (MTS)August 26, 1997
K964873SILKAIR LOW AIRLOSS THERAPYJuly 3, 1997
K964223CLINITRON RITE-HITEMay 28, 1997
K970295FLEXICAIR EXLIPSE PLUSMay 16, 1997
K970074STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)April 3, 1997
K962942TOTALCAREFebruary 3, 1997
K963091VOLLMAN PRONE POSITIONERJanuary 9, 1997
K961437WHEELED STRETCHERJune 3, 1996
K952447HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHERNovember 22, 1995
K951001FLEXICAIR EXLIPSEJune 27, 1995