39 results
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43ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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
Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·June 24, 2015
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)
FDA Enforcement
Class I
·Terminated·Hill-Rom, Inc.·February 10, 2021
TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare SpO2RT¿ 2 Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·March 20, 2013
Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift Systems Product Usage - The Overhead Rail System allows overhead lifts to be mounted to the ceiling allowing versatility for use in lifting situations. It can be used with different Liko ceiling lifts.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·February 27, 2013
TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·July 31, 2013
Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·January 9, 2013
SlingBar Standard. Designed to meet the needs for lifting humans.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·June 12, 2013
SlingBar Wide 670. Designed to meet the needs for lifting humans.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·June 12, 2013
SlingBar 360. Designed to meet the needs for lifting humans.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·June 12, 2013
Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·March 2, 2016
SlingBar 350. Designed to meet the needs for lifting humans.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·June 12, 2013
Hill-Rom 1000 Bed, Product No. P1160. The Hill-Rom 1000 Bed is intended for low to moderate acuity patient in the medical surgical area of the hospital.
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·June 12, 2013