Events

Rappel de Device Recall e.cam Emission Computed Tomography Systems

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 Medical Solutions USA, 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
    61672
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1687-2012
  • Date de mise en oeuvre de l'événement
    2012-05-15
  • Date de publication de l'événement
    2012-05-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108691
  • 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
    System, tomography, computed, emission - Product Code KPS
  • Cause
    Siemens has identified a potential patient safety issue for e.Cam and symbia e camera systems that have had the radial drive motor assembly replaced during a service action. there is a remote chance that during the motor replacement the radial drive gear may have been replaced incorrectly. if the gear is installed incorrectly the mechanical brake may not engage creating a patient hazard if the sys.
  • Action
    On May 15, 2012, Siemens Medical Solutions USA, Inc. sent an "Urgent Field Correction Recall" letter dated April 11, 2012 to all affected customers. The letters informed customers of the potential patient safety issue for e.cam and Symbia E camera systems that have had the radial drive motor assembly replaced during a Service action. Customers were informed that a Siemens Service Engineer will be inspecting the radial drive gear on their camera system to ensure it is functioning correctly. For questions or assistance they were instructed to contact Siemens Medical Solutions USA, Inc. at 800-888-7436.

Device

Device Recall e.cam Emission Computed Tomography Systems
  • Modèle / numéro de série
    Material number 4380213, serial numbers 1018 and 3020;  material number 4380221, serial numbers 0009, 1039, 1047, 1056, 1075, 1094, 1099, 1109, 1137, 1166, 1181 and 1190;  material number 5227397, serial number 1136;  material number 5242826, serial numbers 1005, 1024, 1060, 1065, 1070, 1071, 2046, 2050, 2053, 2059, 2070, 2071, 2111, 2114, 3005, 3007, 3019, 3060, 3092, 3098, 3122, 3124, 4024, 4027, 4035, 4039, 4042, 4044, 4060, 4067 and 4075;  material number 5977066, serial numbers 4092, 4165, 5030, 5048 and 5103;  material number 5977074, serial number 5031;  material number 5984005, serial number 7006;  material number 5989079, serial numbers 7538, 8003, 8009, 8031, 8046, 8097, 8527, 8546, 8652, 8665, 8694, 8730, 8744, 8764 and 08501/7823920;  Material number 5989087, serial numbers 7503, 8018, 8514 and 8542;  material number 5991109, serial numbers 5564, 5649,7009, 7017 and 7038;  material number 5991117, serial number 4005;  material number 5992099, serial numbers 5154, 5157 and 5502;  material number 7324143, serial number 0573;  material number 7760809, serial number 8502;  material number 7760932, serial numbers 8528, 8575 and 9024;  material number 7823920, serial number 8508;  material number 7823946, serial numbers 9088, 9092, 9112, 9128, 9161, 9171, 9203, 9210, 9237, 10036, 10038, 10095, 10097, 10137, 10161, 10239, 10306, 11017, 11040, 11071, 11145, 11186, 11195, 11226, 11291, 11298, 11411, 11419, 11477, 11496, 11505, 11653, 11660, 11762 and 11789; material number 7823953, serial numbers 9024, 11057 and 11139;  material number 7823979, serial number 9013;  material number 10151531, serial numbers 1021 and 1022; and  material number 10151532, serial numbers 1027, 1049, 1134, 1137, 1138, 1317, 1321, 1343 and 1345.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution, US (Nationwide) and the countries of Australia, Belgium, Canada, China, France, Germany, Italy, Japan, Republic of Korea, Mexico, Netherlands, Portugal, Spain, Taiwan and the United Kingdom.
  • Description du dispositif
    e.cam Emission Computed Tomography Systems. Siemens e.cam Emission Imaging Computed Tomography Systems is used for all common nuclear medicine procedures.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60195-2061
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA