Events

Rappel de Device Recall LCSU 4

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 Laerdal Medical Corporation.

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
    76744
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1873-2017
  • Date de mise en oeuvre de l'événement
    2017-01-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154075
  • 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
    Apparatus, suction, ward use, portable, ac-powered - Product Code JCX
  • Cause
    The on/off functionality in the lcsu 4 is controlled by electronic components, one of which might be damaged.
  • Action
    On January 8, 2017 Laerdal Medical distributed Urgent Device Recall Notification Letters to their customers thru Stericycle. The documents were dispatched via standard UPS ground delivery. Laerdal Medical has discovered that the LCSU4 may turn on by itself when connected to a power source and/or may not be able to be turned off with the on/off button without removing the battery or external power source. You can continue to use your suction units until your replacement arrives by following the steps: Exception: Some LCSU 4 units have a RW label on the bottom. These units have been reworked by Laerdal Medical and are not affected by this Field Safety Notice, even if they have manufacturing dates within the 20150501 to 20161028 range. **Check On/Off functionality** You can run a quick test to identify if the unit has failing On/Off functionality: Turn unit on; Turn unit off again. If the unit cannot be turned off using the On/Off button, the unit contains a damaged component. The device should be taken out of service. The safety and effectiveness of the device is not affected by the failure of the On/Off button as long as it has power. Note that even if the unit passes this test, the problem may occur later. The actions below must be taken to ensure continued safe use of the LCSU 4 until you receive a replacement unit. **Actions to be taken to ensure continued safe use of the LCSU 4 until you receive a replacement unit** You can continue to use your LCSU 4 unit until you receive a replacement unit, but it is recommended to implement the following extra safety measures: Store the LCSU 4 unit without the battery connected so that it cannot turn on by itself. Perform routine checks of the On/Off functionality by turning the unit on and off using the On/Off button. All units with failing On/Off functionality should be removed from service. ** Actions to be taken if the On/Off functionality fails during clinical use** If the On/Off functionality fai

Device

Device Recall LCSU 4
  • Modèle / numéro de série
    Affected units are labelled with Manufacturing Dates in the range 20150501 to 20161028.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide
  • Description du dispositif
    Laerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit, 88006201 - LCSU 4, 300 ml, RTCA Complete unit (US), 88006203 - LCSU 4, 300 ml, RTCA Complete unit (UK), 88006240 - LCSU 4, 300 ml, RTCA Complete unit (EUR) and 881152 - Replacement Unit, RTCA; 2) 88005101 - LCSU 4, 800 ml Complete unit (US), 88005103 - LCSU 4, 800 ml Complete unit (UK), ¿ 88005140 - LCSU 4, 800 ml Complete unit (EUR), 88005201 - LCSU 4, 800 ml, RTCA Complete unit (US), 88005203 - LCSU 4, 800 ml, RTCA Complete unit (UK), 88005240 - LCSU 4, 800 ml, RTCA Complete unit (EUR) || & 2) 800 ml (4.3 lbs) canister version - CATALOG #(s): 88005101, 88005201 (RTCA)
  • Manufacturer
    Laerdal Medical Corporation

Manufacturer

Laerdal Medical Corporation
  • Adresse du fabricant
    Laerdal Medical Corporation, PO Box 1840, 167 Myers Corners Rd, Wappingers Falls NY 12590-3869
  • Société-mère du fabricant (2017)
    Laerdal Medical Corporation
  • Source
    USFDA