Events

Rappel de Device Recall Siemens RAPIDLab 1245 System

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 Siemens Healthcare Diagnostics 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
    70203
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1254-2015
  • Date de mise en oeuvre de l'événement
    2014-12-30
  • Date de publication de l'événement
    2015-03-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132496
  • 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
    Bilirubin (total and unbound) in the neonate test system - Product Code MQM
  • Cause
    Neonatal bilirubin (nbili) parameter may have increased variability when the nbili concentration is greater than 12 mg/dl and the thb concentration exceeds the upper reportable range of greater than 25 g/dl.
  • Action
    An Urgent Field Safety Notice was sent by e-mail to all affected Siemens Healthcare Diagnostics Regional offices on December 30, 2014 both in the United States and elsewhere for communication with affected customers. In addition, all affected domestic customers were sent a hard copy of the Urgent Field Safety Notice via Federal Express on December 30, 2014. All affected customers outside the US will be provided a copy of an Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each countries local regulations and procedures. This notice informs consignees of the issue. Consignees are also asked to complete a field effectiveness check form and return it Siemens via fax (312) 275-7795.

Device

Device Recall Siemens RAPIDLab 1245 System
  • Modèle / numéro de série
    All serial numbers.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US nationwide including Puerto Rico, Canada, Mexico, Albania, Algeria, Argentina, Austria, Bahrain, Belgium, Bosnia Herzegovina, Botswana, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Ivory Coast, Kazakhstan, Kuwait, Latvia, Lebanon, Lesotho, Lithuania, Luxembourg, Macedonia, Netherlands, New Caledonia, Norway, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, U.A.E., United Kingdom, Vatican City, Venezuela, White Russia/Belarus.
  • Description du dispositif
    RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179. || The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb.
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Adresse du fabricant
    Siemens Healthcare Diagnostics Inc, 2 Edgewater Drive, Norwood MA 02062
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA