Events

Rappel de Device Recall PHILIPS MULTIDIAGNOST ELEVA

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 Philips Electronics North America 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
    74731
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2305-2016
  • Date de mise en oeuvre de l'événement
    2016-07-19
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148332
  • 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, x-ray, angiographic - Product Code IZI
  • Cause
    The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag.
  • Action
    On July 19, 2016, Philips sent a Field Safety Notice to all affected customers. Philips Field Service Engineers will add an independent safety catch free of charge.

Device

Device Recall PHILIPS MULTIDIAGNOST ELEVA
  • Modèle / numéro de série
    All serial numbers.  708034 System serial numbers 6, 264, 112, 106, 233, 136, 31, 83, 224, 144, 71, 123, 5, 249, 134, 103, 266, 97, 132, 61, 19, 82, 196, 3, 12, 39, 244, 197, 119, 204, 75, 151, 69, 70, 37, 115, 55, 200, 180, 175, 78, 93, 234, 130, 142, 53, 113, 65, 27, 242, 202, 14, 208, 247, 261, 225, 28, 11, 110, 25, 128, 171, 81, 237, 211, 54, 76, 163, 207, 216, 122, 135, 205, 63, 238, 254, 262, 72, 1, 206, 187, 52, 143, 154, 155, 156, 73, 150, 98, 248, 80, 22, 133, 209, 167, 265, 105, 217, 79, NTS0427, 129, 13, 15, 16, 17, 18, 24, 84, 146, 41, 190, 10, 194, 125, 268, 177, 109, 42, 43, 44, 172, 213, 181, 212, 189, 26, 95, 9, 4, 117, 251, 2, 48, 183, 157, 245, 116, 62, 56, 160, 152, 127, 94, 174, 176, 259, 50, 58, 51, 277, 68, 159, 77, 40, 199, 253, 114 257, 246, 23, 147, 162, 29, 66, 47, 179, 221, 126, 195, 220, 161, 46, 182, 278, 138, 222, 269, 36, 96, 201, 137, 223, 228, 219, 60, 272, 111, 35, 85, 186, 38, 120, 170, 185, 32, 64, 30, 100, 101, 104, 235, 34, 148, 149, 67, 118, 121, 241, 210, 191, 255, 168, 273, 33, 240, 131, 88, 8, 193.  708037 System Serial numbers 48, 85, 17, 53, 2, 125, 170, 180, 157, 33, 49, 200, 18, 84, 216, 36, 116, 234, 201, 135, 236, 39, 96, 34, 19, 54, 132, 5, 154, 83, 151, 29, 21, 110, 175, 228, 183, 20, 4, 91, 69, 44, 205, 89, 164, 240, 165, 13, 51, 121, 174, 120, 43, 160, 185, 171, 23, 209, 95, 144, 50, 141, 156, 80, 94, 150, 190, 41, 10, 113, 93, 98, 196, 38, 64, 86, 72, 73, 230, 56, 22, 140, 181, 192, 37, 12, 191, 195, 155, 221, 182, 133, 246, 149, 169, 61, 62, 100, 101, 102, 103, 219, 226, 227, 46, 97, 99, 55, 3, 7, 8, 63, 233, 106, 114, 206, 207, 108, 213, 32, 163, 24, 92, 176, 212, 179, 14, 193, 214, 6, 30, 173, 222, 146, 115, 90, 177, 59, 25, 189, 118, 218, 153, 107, 161, 31, 27, 112, 42, 104 76, 26, 217, 35, 124, 139, 15, 66, 241, 245, 40, 239, 123, 58, 88, 172, 129, 81, 136, 159, 244, 238, 82, 65, 249, 70, 142, 188, 178, 158, 128, 117, 148, 45, 203, 79, 229, 199, 119, 126, 152, 71, 52, 60, 197, 198, 87, 105.  708038 System serial numbers 158, 146, 196, 164, 37, 63, 213, 209, 218, 252, 255, 256, 7, 96, 170, 45, 173, 100, 51, 155, 83, 210, 90, 212, 159, 217, 226, 1, 53, 181, 163, 140, 47, 95, 148, 39, 26, 10, 114, 108, 71, 141, 115, 61, 16, 42, 33, 14, 36, 106, 112, 35, 137, 48, 60, 157, 25, 50, 54, 156, 116, 12, 68, 105, 3, 11, 161, 204, 205, 15, 232, 9, 220, 109, 227, 224, 201, 250, 251, 91, 92, 93, 207, 72, 228, 171, 118, 57, 189, 132, 129, 216, 138, 29, 24, 31, 2, 119, 139, 5, 28, 49, 22, 23, 208, 80, 98, 30, 125, 193, 167, 168, 169, 75, 81, 131, 221, 211, 41, 160, 192, 43, 44, 154, 97, 6, 219, 8, 79, 135, 88 107, 65, 194, 126, 69, 247, 248, 249, 13, 215, 78, 243, 245, 246, 175, 38, 177, 253, 191, 32, 259, 235, 264, 258, 52, 67, 111, 257, 94, 142, 143, 260, 121, 236, 268, 265, 74, 101, 182, 174, 124, 239, 4, 172, 263, 254, 149, 151, 64, 183, 184, 76, 152, 188, 261, 242, 244, 34, 162, 147, 241, 134, 178, 237, 176.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution. US nationwide, Canada, Algeria, ARGENTINA, Australia, Austria, Belgium, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Germany, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jersey, Jordan, Republic of Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Philippines, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, TURKEY, Ukraine, United Arab Emirates, and United Kingdom.
  • Description du dispositif
    MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
  • Manufacturer
    Philips Electronics North America Corporation

Manufacturer

Philips Electronics North America Corporation
  • Adresse du fabricant
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA