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Sources: EU EUDAMED, US FDA
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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
Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and in suitable rooms in private residences. They may not, however, be used for transportation purposes. Any deviation from this use is expressly excluded from possible liability claims.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·August 17, 2016
Progressa Bed - AC-powered adjustable hospital bed
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·April 18, 2018
Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·July 1, 2015
Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds 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.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·September 10, 2014
Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·July 4, 2012
Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds 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. They are not intended for use as general hospital beds.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·August 1, 2012
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.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·November 9, 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.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·September 14, 2016