Events

Rappel de Device Recall Liko Standard Slingbar 450.

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Hill-Rom, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    62413
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0622-2013
  • Date de mise en oeuvre de l'événement
    2012-12-06
  • Date de publication de l'événement
    2012-12-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-11-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110438
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Lift, patient, non-ac-powered - Product Code FSA
  • Cause
    Liko/hill-rom has received reports from facilities which indicate that serious injuries have been received related to the standard sling bar 450. there have been 6 complaints of injury related to the product over the past 32 years (6 out of 838,687,856 estimated patient uses). one of the injuries was associated with a patient during use, four injuries occurred when the slingbar was not in use wher.
  • Action
    Hill-rom sent an URGENT MEDICAL DEVICE RECALL notification letter dated December 6, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.. Customers were requested to please read, fill in completely, and return the Response Form to Hill-Rom immediately. This information will be compiled and reported to the applicable regulatory governing bodies. If we do not receive your response we will be required to contact you asking for your response. Continue to follow safe lifting practices, and do not allow unauthorized persons, especially children, to play around or operate the lift. If you have any questions concerning this Customer Safety Notification, please contact Hill-Rom Technical Support at 800-445-3720.

Device

Device Recall Liko Standard Slingbar 450.
  • Modèle / numéro de série
    The Liko Standard Slingbar 450 accessory has been supplied under multiple product numbers and combined with the sale of mobile lifts. The Standard Slingbar 450 is not serialized and has been distributed between January 1980 and the present. Here are the different Product Numbers in which the Slingbar has been shipped under: Standard Slingbar 450: 20090029, 20190024, 20190041, 31190015, 31290017, 31290043, 3156001, 3156003, 3156007, 3156014, 3156016, 31590043, and 5019013.  Packaged with Golvo up to April of 2005: 2000001, 2000003, 2000005, 2000006, 2000007, 2000008, 2000009, 2000009CH, 2000009D, 2000009DK, 2000009EU, 2000009F, 2000009FIN, 2000009J, 2000009N, 2000009NL, 2000009UK, 2000009U5, 2000010, 20000100, 20000100K, 2000010EU, 2000010F, 2000010FIN, 2000010H, 2000010J, 2000010N, 2000010NL, 2000010UK, 200001OU5, 2000050, 2000051, 2000061, IN8000, and IN8061.  Packaged with Viking up to December of 2004: 2040003, 2040003L, 2040004, 2040005, 2040006, 2040007, 2040013, 2040014, 2040015, 2040033, 2040034, and 2040035.  Packaged with LikoLight up to December of 2004: 2030001 and 2030001H.  Packaged with Uno lifts up to present: 2010001, 2010002, 2010003, 2010003D, 2010003EU, 2010003F, 2010003H, 2010003N, 2010003UK, 2010003US, 2010004, 2010004D, 2010004EU, 2010004F, 2010004H, 2010004N, 2010004UK, 2010004US, 2010005, 20100050, 2010005EU, 2010005F, 2010005N, 2010005UK, 2010005U5, 2010011, 2010012, 5E2010004, and 5E2010011.  Packaged with Caroli lifts up to present: 5011001.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US (nationwide) including the states of AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MA, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OK, OR, PA, TN, TX, UT, WA, WV, and WY., and the country Canada, We have not yet defined our European or International facilities at this time.
  • Description du dispositif
    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.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Adresse du fabricant
    Hill-Rom, Inc., 1069 State Route 46 East, Batesville IN 47006-7520
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA