Hill-Rom Inc.
Ladson, SC, US
HILL-ROM, INC. appears in FDA device records in Ladson, SC. FDA records list 38 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 136 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Hill-Rom Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Trumpf Medical Systems, Inc.510(k), enforcement report, recall
- Virtus, Inc.recall
510(k) clearance history
FDA records hold 38 510(k) clearances for Hill-Rom Inc. between 1986 and 2026. The busiest year on record is 1997, with 7. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 2 |
| 1992 | 5 |
| 1993 | 5 |
| 1994 | 1 |
| 1995 | 5 |
| 1996 | 1 |
| 1997 | 7 |
| 1998 | 4 |
| 2001 | 2 |
| 2011 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260211 | Dashboard (P007000) | MSX | Substantially Equivalent | |
| K202018 | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation | BZQ | Substantially Equivalent | |
| K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation | BZQ | Substantially Equivalent | |
| K143414 | Hill-Rom Wireless Connectivity Module | IOQ | Substantially Equivalent | |
| K122473 | TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 | IOQ | Substantially Equivalent | |
| K112502 | PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 | INK | Substantially Equivalent | |
| K013709 | HILL-ROM PRIMAVIEW MONITOR SYSTEM | FET | Substantially Equivalent | |
| K011693 | TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 | FSY | Substantially Equivalent | |
| K973705 | CONTOR TABLE SURFACE | DWJ | Substantially Equivalent | |
| K981081 | BRIGHTSTAR | FSY | Substantially Equivalent | |
| K972111 | RUMORS DYNAMIC AIR THERAPY UNIT | IKZ | Substantially Equivalent | |
| K971366 | INCUWARMER | FMT | Substantially Equivalent | |
| K970636 | TOTALCARE., MODULAR THERAPY SYSTEM (MTS) | IOQ | Substantially Equivalent | |
| K964873 | SILKAIR LOW AIRLOSS THERAPY | IOQ | Substantially Equivalent | |
| K964223 | CLINITRON RITE-HITE | INX | Substantially Equivalent | |
| K970295 | FLEXICAIR EXLIPSE PLUS | IOQ | Substantially Equivalent | |
| K970074 | STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) | FMT | Substantially Equivalent | |
| K962942 | TOTALCARE | FNL | Substantially Equivalent | |
| K963091 | VOLLMAN PRONE POSITIONER | IPT | Substantially Equivalent | |
| K961437 | WHEELED STRETCHER | FPO | Substantially Equivalent | |
| K952447 | HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER | FPO | Substantially Equivalent | |
| K951001 | FLEXICAIR EXLIPSE | IOQ | Substantially Equivalent | |
| K950756 | PULMONEX DYNAMIC AIR THERAPY UNIT | IKZ | Substantially Equivalent | |
| K944580 | FLEXSYS MOBILEMATE EQUIPMENT STAND | FOX | Substantially Equivalent | |
| K945729 | DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE | IOQ | Substantially Equivalent | |
| K942904 | STABILET | FMT | Substantially Equivalent | |
| K924420 | MEDICAL DISPOSABLE BEDDING | KNC | Substantially Equivalent | |
| K926140 | VACUUM POWER BODY FLUID SUCTION APPARATUS | KDP | Substantially Equivalent | |
| K922809 | GENERAL PROCEDURAL STRETCHERS (P880- P886) | FPO | Substantially Equivalent | |
| K922808 | HILL-ROM VIA STRETCHER (P1300 - P1303) | FPO | Substantially Equivalent | |
| K915779 | AFFINITY BED MODEL 3600 SERIES | KNC | Substantially Equivalent | |
| K922352 | THE ADVANCE SERIES FROM HILL-ROM | FNL | Substantially Equivalent | |
| K915437 | CRITICAL CARE HOSPITAL BED (ICU/CCU) | FNL | Substantially Equivalent | |
| K921528 | HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM | IQA | Substantially Equivalent | |
| K914309 | THE GENESIS BED FROM HILL-ROM, MODEL 355 SERIES | HDD | Substantially Equivalent | |
| K913945 | STABILET INFANT RADIANT WARMER MODEL 2000C | FMT | Substantially Equivalent | |
| K864186 | HILL-ROM CENTURY CC MODELS 892 &894 (RADIOLUCENT) | FNL | Substantially Equivalent | |
| K864172 | HILL-ROM CENTURY CC, MODELS 891 & 893 WEIGHING SYS | FNL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1824206 | 1824206 | HILL-ROM, INC. | 1069 State Route 46 East, Batesville, IN 47006 US | 2026 | and 20 more, listed in full below |
| 2027454 | 2027454 | HILL-ROM, INC. | 1501 Nowell Road, Raleigh, NC 27607 US | 2026 | |
| 1066635 | 3003184737 | Hill-Rom Company, Inc. | 4279-U Crosspoint Drive, Ladson, SC 29456 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ILZAccessories, Traction
- IKXAid, Transfer
- HSTApparatus, Traction, Non-Powered
- NNWBag, Urine Collection, Leg, For External Use, Non-Sterile
- OSIBariatric Bed
- NZGBassinet, Hospital
- FNLBed, Ac-Powered Adjustable Hospital
- INXBed, Air Fluidized
- IOQBed, Flotation Therapy, Powered
- FNJBed, Manual
- IKZBed, Patient Rotation, Powered
- KMEBedding, Disposable, Medical
- KQMCamera, Surgical And Accessories
- KMNChair And Table, Medical
- INNChair, Adjustable, Mechanical
- KQZComponent, Traction, Non-Invasive
- KZFDevice, Medical Examination, Ac Powered
- FMRDevice, Transfer, Patient, Manual
- PGWEar, Nose, And Throat Stereotaxic Instrument
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- IWYHolder, Head, Radiographic
- FQPLamp, Operating-Room
- FTDLamp, Surgical
- FSALift, Patient, Non-Ac-Powered
- FTALight, Surgical, Accessories
- FSYLight, Surgical, Ceiling Mounted
- FSSLight, Surgical, Floor Standing
- FSQLight, Surgical, Instrument
- IKYMattress, Flotation Therapy, Non-Powered
- OUGMedical Device Data System
- KMIMonitor, Bed Patient
- BZQMonitor, Breathing Frequency
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- HAWNeurological Stereotaxic Instrument
- FWZOperating Room Accessories Table Tray
- IPTOrthosis, Thoracic
- FMPProtector, Skin Pressure
- KDPRegulator, Vacuum
- FOXStand, Infusion
- FPOStretcher, Wheeled
- INKStretcher, Wheeled, Powered
- CCXSupport, Patient Position
- ILQSystem, Communication, Powered
- IQASystem, Environmental Control, Powered
- MSXSystem, Network And Communication, Physiological Monitors
- DWJSystem, Thermal Regulating
- KNCTable, Obstetric (And Accessories)
- HDDTable, Obstetrical, Ac-Powered (And Accessories)
- GDCTable, Operating-Room, Electrical
- KXJTable, Radiologic
- JEATable, Surgical With Orthopedic Accessories, Ac-Powered
- ITJWalker, Mechanical
- FMTWarmer, Infant Radiant
Recall records
Showing 25 of 136| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0783-2022 | (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR ESYST WIDE 3102517 TR CARR. NORMAL/LOWER. LR 3102506 TR CARRIER WIDE/RAISED ML 3102519 TR CARR. LOW.LR 30MM/PAIR 3102511 TR CARRIER NORMAL, LR 3102531 TRAVERSE RL CARRIER STD/RAISED 3102512 TR CARRIER WIDE, LR 3102532 TRAVERSE RL CARRIER WD/RAISED 3102513 TR CARRIER SLIM, LR 3102562 TR CARRIER, PARALLEL/WIDE | Traverse rail carriage delivered with non-conforming screws are too short to ensure appropriate installation. There is potential that the screws are unable to secure the traverse rail appropriately and could loosen over time causing the rail system to fall, potentially causing injury to caregivers and/or patients | Class II | Terminated | |
| Z-0640-2022 | Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015 | Missing bushing on Liko M220 and M230 causing wear and potential for patient falling | Class II | Open, Classified | |
| Z-0639-2022 | Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010 | Missing bushing on Liko M220 and M230 causing wear and potential for patient falling | Class II | Open, Classified | |
| Z-0402-2022 | These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Product was rebranded from NaviCare to Voalte in 2020 | An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced. | Class II | Terminated | |
| Z-2601-2021 | LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. | Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from. | Class II | Open, Classified | |
| Z-2600-2021 | LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. | Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from. | Class II | Open, Classified | |
| Z-2599-2021 | Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. | Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from. | Class II | Open, Classified | |
| Z-2598-2021 | FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. | Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from. | Class II | Open, Classified | |
| Z-2597-2021 | OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Model Number: 3156056 | Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from. | Class II | Open, Classified | |
| Z-2156-2021 | Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market Model Numbers: P3700B, P3700C, P3700D, & P3700E | Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could result in injury to the user due to a fall. | Class II | Terminated | |
| Z-0925-2021 | Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in healthcare, intensive care and rehabilitation. Affected devices: Liko Multirall 200 (product number 3130001) Universal SlingBar 450 R2R (product number 3156095) Universal SlingBar 350 R2R (product number 3156094) Carriage D45 with Double Hook (product number 3136100) Extension belt 300-400 mm (product number 3136226) Extension belt 400-600 mm (product number 3136227) Extension belt 600-1000 mm (product number 3136228) Extension belt 1000-1400mm (product number 3136229) | Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, leading to the Multirall lift becoming detached from the rail system, potentially resulting in the fall of both the lift motor and the patient | Class I | Terminated | |
| Z-2738-2020 | Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy. | Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury. | Class II | Terminated | |
| Z-2737-2020 | Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy. | Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury. | Class II | Terminated | |
| Z-2246-2020 | Centrella Smart+ Bed, Catalog Number P7900 | The Bed Exit System may fail to send a remote alert through the nurse call system if a remote alert was previously sent and cancelled at the in-room nurse call wall unit. | Class II | Terminated | |
| Z-1554-2020 | NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18 2. Centrella (all versions) 3. Progressa (firmware version 1.15.0.0) | There is a software issue which may result in failure to monitor or control patient's bed exit mechanism. | Class II | Terminated | |
| Z-1319-2018 | Progressa Bed - AC-powered adjustable hospital bed | A component used within the braking system may break resulting in one or more brake pedals on the bed staying in brake or not being engaged which could result in unwanted bed movement and possible patient or user injury. | Class II | Terminated | |
| Z-0824-2018 | Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching. | The radiated emission from the TruVidia" Wireless Receiver is above the normative accepted limits, in which the radiated emission may interact with other devices in the operating room and cause them not to function properly. | Class II | Terminated | |
| Z-1816-2017 | TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A). | The bed exit alarm may not function properly if the alarm has been armed for a period longer than seventy-two (72) hours without the alarm being triggered by patient movement or removal of patient weight within that time period. | Class II | Terminated | |
| Z-0391-2017 | OR Table, Top U26 H V, Model # 1909793; OR Table Top U26 H V U, Model # 1909794; OR Table Top U24 H V, Model # 1909796; OR Table Top U24 H V U, Model # 1909797; OR Table Top U24 H V W, Model # 1909798; OR Table Top U14 H V, Model # 1909799 Product Usage: Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Patient transport on the operating table top from a patient transfer system to the operating theater or from the operating theater to a patient transfer system. | Trumpf has identified six incidents of pinched cables. | Class II | Terminated | |
| Z-0326-2017 | Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL. | Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exists that if the Ceiling Bracket 71 with a larger center hole is used for a concrete ceiling Ultra System installation with the M8 screw and the safe working load is exceeded, the system could fall. | Class II | Terminated | |
| Z-2750-2016 | Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are shipped as a quantity of two (2) together as shown with the nylon strapping. These are shipped in standard freight containers. There is no secondary packaging. | Class II | Terminated | ||
| Z-0043-2017 | Operating Table TruSystem 7000 U, Material Number 1604788; Operating Table TruSystgem 7000 U (MB), Material Number 1604786 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system | Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. | Class II | Terminated | |
| Z-0042-2017 | Floor Mounting Column TS 7500 U, Material Number 1730732; Floor Mounting Column ARTIS, Material Number 1501878 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system. | Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. | Class II | Terminated | |
| Z-0041-2017 | Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system. | Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. | Class II | Terminated | |
| Z-0040-2017 | Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system | Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain