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Sources: EU EUDAMED, US FDA
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Philips "HeartStart Home" defibrillator, model M5068A and is sold in the US over the counter. The HeartStart is an automated external defibrillator for use on site and consists of a computer with digital interface and cartridge containing pads.
FDA Recall
Terminated
·Philips Medical Systems·Product code NSA·April 30, 2008
Heartstart HS1 Defibrillator Model M5068A
FDA Recall
Terminated
·Philips Medical Systems·Product code NSA·November 2, 2009
LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233
FDA Recall
Terminated
·Esa Biosciences, Inc.·Product code DOF·May 19, 2005
ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142
FDA Recall
Terminated
·Esa Biosciences, Inc.·Product code DOF·September 20, 2007
ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762
FDA Recall
Terminated
·Esa Biosciences, Inc.·Product code DOF·September 20, 2007
MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions.
FDA Recall
Terminated
·Medistim Asa Okernveien·Product code DPW·April 25, 2017
Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No
FDA Recall
Open, Classified
·Medistim Asa Okernveien·Product code DPW·September 26, 2025
NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
FDA Recall
Open, Classified
·NOA Medical Industries Inc·Product code IKX·November 5, 2024
Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 05J83-001; The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025.
FDA Recall
Terminated
·Abbott Molecular·Product code MVU·December 22, 2006
Flite Clip Slings; patient specific disposable sling; Manufactured in Belgium for Medibo NV, Heikant 5, 3930 Hamont Achel, Belgium; these slings are intended for use with Arjo and BHM Passive Patient Lifts and Ceiling Lifts with four-point hanger bars intended for use with clip slings. The slings are used to assist with the lifting and transportation of a patient in the horizontal or other required position from one place to another and used only by appropriately trained caregivers.
FDA Recall
Terminated
·ArjoHuntleigh·Product code FSA·February 26, 2009
Sling Rope/Connector Assembly Kits for the Sara and Sara Nova standing and raising aids; the kit is comprised of 2 x 200 cm ropes, 2 knobs, 2 sling connectors, 2 socket cap screws, 2 nylon nuts and 2 spacers; Arjo Inc., 50 N. Gary Avenue, Roselle, IL 60172; Model KS1006
FDA Recall
Terminated
·Arjo, Inc.·Product code FSA·October 30, 2006
Universal SlingBar 350 Product Number: 3156074 Used with the: Viking XS, Viking S, Viking M, Viking L Patient Lifts
FDA Recall
Terminated
·Liko AB Alvik·Product code FSA·July 1, 2008
Maxi Move Patient Lift with Lock & Load System (Combi Hanger); Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Models KMBB4CLU2FUS, KMBB4MLU2FUS, KMBB4MSU2FUS, KMBB4NLX2FUS, KMBB4NSX2FUS, KMBB4OLU2FUS, KMBB4OSU2FUS, KMBB4PLX2FUS, KMBB4PSX2FUS, KMBB4QLU2FUS, and KMBB4RLX2FUS. The lifter is intended to be used under the direct supervision of trained personnel for the transfer of residents from one location to another.
FDA Recall
Terminated
·Arjo, Inc.·Product code FSA·September 8, 2008
Liko Sabina Comfort Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise.
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FSA·January 27, 2011
Liko Sabina 200 Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise.
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FSA·January 27, 2011
Liko Sabina EM Lift, Liko, Sweeden. The Sabina and Capella sit-to-stand lifts are especially designed for people who have difficulty in standing on their own. The lifts are intended to be used with patients who are able to bear weight on their legs and actively participate in the standing exercise.
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FSA·January 27, 2011
Molift Smart 150
FDA Recall
Terminated
·Moller Vital Hadelandsvegan 2·Product code FSA·February 15, 2013
SlingBar 360. Designed to meet the needs for lifting humans.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code FSA·April 30, 2013
BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
FDA Recall
Terminated
·Prism Medical Services USA·Product code FSA·May 23, 2013
Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Model 700-19425. Intended to be used for general transfers in hospitals.
FDA Recall
Terminated
·Arjo, Inc. dba ArjoHuntleigh·Product code FSA·January 21, 2013