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Sources: EU EUDAMED, US FDA
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FDA Recall
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Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code HDD·September 6, 2007
Hill-Rom Affinity Four Birthing Bed, Hill-Rom Company, Inc., Batesville, Indiana; Model P3700B. Intended to be used as birthing beds for momen of child bearing age in an labor, delivery, recovery or postpartum setting in acute care.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code HDD·November 16, 2009
Hill-Rom 70 Semi-Electric Bed, Hill-Rom Company, Batesville, IN.; Model HS-968. The bed is a general purpose bed for use with low to medium acuity patients in the home care environment.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code FNL·November 11, 2008
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.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code KNC·July 15, 2016
Envision E700 Low Airloss Therapy Surface, Made By Hill-Rom Manufacturing, Inc., Charleston, SC. The Envision E700 Low Airloss Therapy Surface helps prevent and treat stage III and stage IV pressure ulcers in patients who weigh between 70 lb and 400 lb and are between 4'11" and 6' 4" in height.
FDA Recall
Terminated
·Hill-Rom Manufacturing, Inc.·Product code IOQ·June 19, 2008
Flexicair MC3 (Model number: M4000) Low Airloss Therapy Units For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure.
FDA Recall
Terminated
·Hill-Rom Manufacturing, Inc.·Product code IOQ·December 6, 2010
Flexicair II (Model number 13000) Low Airloss Therapy Units For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure.
FDA Recall
Terminated
·Hill-Rom Manufacturing, Inc.·Product code IOQ·December 6, 2010
Clinitron At Home Bed headboard and foot side rails. The Clinitron At Home Air Fluidized Therapy Unit provides a pressure-relieving sleep surface for patients in the home environment. It helps enable patients with pressure sores to heal their wounds
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code INX·February 3, 2012
Clinitron Rite Hite Bed headboard and foot side rails. The Clinitron Rite Hite Air Fluidized Therapy Unit is a patient management system that combines air fluidized therapy and low airloss therapy technologies together on a low-height frame. The lower body section provides air fluidized therapy, and the upper body section provides low airloss therapy.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code INX·February 3, 2012
Zimmer Patient Helper Reinforce Overhead Bar for Hill-Rom Versa Care beds; Zimmer Inc., Warsaw, The product is a L shaped bar that is used with hospital beds set up for traction. The bar allows mounting of a trapeze to help the patient pull themselves up when in the hospital bed. IN; Prod. Nos. 00-2700-965-02 and 00-0965-001-00.
FDA Recall
Terminated
·Zimmer Inc.·Product code IKX·July 7, 2008
Zimmer Freestanding Patient Helper for Hill-Rom Totalcare beds; Zimmer Inc., Warsaw, IN; Prod. Nos. 00-2700-965-00 and 00-0965-001-00. The product is a L shaped bar that is used with hospital beds set up for traction. The bar allows mounting of a trapeze to help the patient pull themselves up when in the hospital bed.
FDA Recall
Terminated
·Zimmer Inc.·Product code IKX·July 7, 2008
Zimmer Patient Helper Reinforced Overhead Bar for Hill-Rom beds with removable headboards; Zimmer Inc., Warsaw, IN; Prod. Nos. 00-0965-000-00 and 00-0965-001-00. The product is a L shaped bar that is used with hospital beds set up for traction. The bar allows mounting of a trapeze to help the patient pull themselves up when in the hospital bed.
FDA Recall
Terminated
·Zimmer Inc.·Product code IKX·July 7, 2008
Hill-Rom Newborn bassinet; model P248
FDA Recall
Terminated
·Hill-Rom, Inc.·June 20, 2003
SlingBar 360. Designed to meet the needs for lifting humans.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code FSA·April 30, 2013
Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal SlingBar" 450, Universal SlingBar" 450 QRH, Universal SlingBar" 450 R2R, Universal SlingBar" 600 Universal SlingBar" 600 QRH Component of Liko Lifts Product Usage: Universal SlingBar 350 It is commonly used for lifting children. Universal SlingBar 350 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 450 Is appropriate in most cases and with most slings. Is installed on most lifts on delivery (does not apply to Viking XL). Universal SlingBar 450 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 600 It is intended for use with the ComfortSling Plus mod 300/310 and 350/360, or with slings the intention of which is to overlap the leg supports, Universal SlingBar 600 is available with two assembly options - fixed assembly and Quick-release Hook (QRH).
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code FSA·March 8, 2016
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)
FDA Recall
Terminated
·Hill-Rom Inc.·Product code KMI·February 14, 2020
FlexoStretch Model Number: 3156057 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
FDA Recall
Open, Classified
·Hill-Rom, Inc.·Product code FSA·August 11, 2021
(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
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code FSA·January 14, 2022
Hill-Rom Newborn bassinet; model P247
FDA Recall
Terminated
·Hill-Rom, Inc.·June 20, 2003
Hill-Rom Affinity Four Birthing Bed, Model P3700B. Note: Not distributed in the U.S.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code KNC·November 21, 2007