Hill-Rom, Inc.
FDA Regulatory Profile
Hill-Rom, Inc. appears in FDA public data with 37 recalls — including 1 Class I (most serious) —, 36 510(k) clearances, 13 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0783-2022, Class II) was initiated on January 14, 2022. Its most recent 510(k) clearance was granted on March 4, 2021.
Summary
- Total Recalls
- 37 (1 Class I)
- 510(k) Clearances
- 36
- Inspections
- 13
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0783-2022 | Class II | (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail | January 14, 2022 |
| Z-0640-2022 | Class II | Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015 | December 23, 2021 |
| Z-0639-2022 | Class II | Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010 | December 23, 2021 |
| Z-0402-2022 | Class II | These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 | October 14, 2021 |
| Z-2598-2021 | Class II | FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adju | August 11, 2021 |
| Z-2597-2021 | Class II | OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjus | August 11, 2021 |
| Z-2599-2021 | Class II | Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily | August 11, 2021 |
| Z-2601-2021 | Class II | LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (o | August 11, 2021 |
| Z-2600-2021 | Class II | LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily | August 11, 2021 |
| Z-2156-2021 | Class II | Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, D | May 28, 2021 |
| Z-0925-2021 | Class I | Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in | December 18, 2020 |
| Z-2737-2020 | Class II | Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary | June 30, 2020 |
| Z-2738-2020 | Class II | Centrella Smart+ Bed, Catalog No. P7900 - Product Usage: intended to be used to treat or prevent pul | June 30, 2020 |
| Z-2246-2020 | Class II | Centrella Smart+ Bed, Catalog Number P7900 | April 30, 2020 |
| Z-1554-2020 | Class II | NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient S | February 14, 2020 |
| Z-1319-2018 | Class II | Progressa Bed - AC-powered adjustable hospital bed | January 12, 2018 |
| Z-1816-2017 | Class II | TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitori | February 23, 2017 |
| Z-0326-2017 | Class II | Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: M | August 9, 2016 |
| Z-2750-2016 | Class II | Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a | July 15, 2016 |
| Z-2376-2016 | Class II | Volker 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-Number | Device | Date |
|---|
| K202018 | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration | March 4, 2021 |
| K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals | May 7, 2018 |
| K143414 | Hill-Rom Wireless Connectivity Module | March 10, 2015 |
| K122473 | TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 | June 3, 2013 |
| K112502 | PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 | September 19, 2011 |
| K013709 | HILL-ROM PRIMAVIEW MONITOR SYSTEM | November 16, 2001 |
| K973705 | CONTOR TABLE SURFACE | August 7, 1998 |
| K981081 | BRIGHTSTAR | April 29, 1998 |
| K972111 | RUMORS DYNAMIC AIR THERAPY UNIT | February 2, 1998 |
| K971366 | INCUWARMER | January 5, 1998 |
| K970636 | TOTALCARE., MODULAR THERAPY SYSTEM (MTS) | August 26, 1997 |
| K964873 | SILKAIR LOW AIRLOSS THERAPY | July 3, 1997 |
| K964223 | CLINITRON RITE-HITE | May 28, 1997 |
| K970295 | FLEXICAIR EXLIPSE PLUS | May 16, 1997 |
| K970074 | STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D) | April 3, 1997 |
| K962942 | TOTALCARE | February 3, 1997 |
| K963091 | VOLLMAN PRONE POSITIONER | January 9, 1997 |
| K961437 | WHEELED STRETCHER | June 3, 1996 |
| K952447 | HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER | November 22, 1995 |
| K951001 | FLEXICAIR EXLIPSE | June 27, 1995 |