Events

Rappel de Philips Healthcare MobileDiganost wDR

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 Sedecal S.A..

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
    70237
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1040-2015
  • Date de mise en oeuvre de l'événement
    2014-08-06
  • Date de publication de l'événement
    2015-02-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132614
  • 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
    Mobile x-ray system - Product Code IZL
  • Cause
    Reports of unexpected movement.
  • Action
    URGENT - Field Safety Notice letters dated August 6, 2014 were sent to all consignees of record. The letters instructed consignees: 1) The unit is equipped with a safety switch in the drive handle. If the drive handle is released the unit will stop; 2) Do not try to correct unintended movement using the controls on the drive handle; 3) Instead, stop the system immediately by releasing the drive handle entirely; 4) Alternatively, the emergency button can be pressed; 5) Take special care when the system crosses metal strips or plates on the floor or enters an elevator, as these are situations where electrostatic discharge is likely to occur; and, 6) Should the customer feel uncertain regarding this action, he/she can contact Philips Healthcare.

Device

Philips Healthcare MobileDiganost wDR
  • Modèle / numéro de série
    Serial Numbers: 12000166 , 13000046 , 13000047 , 13000048 , 13000049 , 13000053 , 13000054 , 13000055 , 13000056 , 13000057 , 13000058 , 13000060 , 13000064 , 13000070 , 13000071 , 13000071 , 13000075 , 13000077 , 13000078 , 13000079 , 13000085 , 13000090 , 13000092 , 13000093 , 13000094 , 13000109 , 13000117 , 13000127 , 13000139 , 13000140 , 13000141 , 13000142 , 13000143 , 13000144 , 13000145 , 13000158 , 13000167 , 13000168 , 13000169 , 13000196 , 13000199 , 13000200 , 13000201 , 13000202 , 13000203 , 13000204 , 13000205 , 14000004 , 14000005 , 14000006 , 14000008 , 14000009 , 14000010 , 14000011 , 14000013 , 14000014 , 14000015 , 14000016 , 14000017 , 14000019 , 14000024 , 14000026 , 14000029 , 14000031 , 14000032 , 14000033 , 14000034 , 14000037 , 14000038 , 14000041 , 14000043 , 14000046 , 14000047 , 14000048 , 14000049 , 14000050 , 14000051 , 14000052 , 14000069 , 14000072 , 14000075 , 14000077 , 14000078 , 14000079 , 14000080 , 14000081 , 14000082 , 14000083 , 14000084 , 14000085 , 14000086 , 14000087 , 14000088 , 14000089 , 14000103 , 14000106 , 14000109 , 14000112 , 14000116 , 13000163,  13000165,  13000177,  14000022,  14000028,  485059/SN11000013 , 485060/SN11000015 , 485061/SN11000012 , 485062/SN11000009 , 488169/SN11000011 , 488171/SN11000068 , 489088/SN11000040 , 489089/SN11000016 , 489616/SN11000033 , 489694/SN11000035 , 489695/SN11000036 , 489696/SN11000037 , 490027/SN11000034 , 490221/SN11000039 , 492417/SN11000048 , 493364/SN12000022 , 493462/SN12000023 , 493565/SN11000048 , 493566/SN11000047 , 494060/SN11000070 , 494061/SN11000071 , 494062/SN11000072 , 494063/SN11000073 , 494064/SN11000074 , 494065/SN11000075 , 494456/SN11000055 , 494464/SN11000065 , 494864/SN11000060 , 494865/SN11000056 , 494866/SN11000062 , 494867/SN11000051 , 495286/SN11000061 , 495938/SN12000007 , 495939/SN12000008 , 496387/SN12000003 , 496401/SN12000059 , 496446/SN11000082 , 497572/SN12000112 , 497715/SN11000080 , 500466/SN12000045 , 500467/SN12000060 , 500468/SN12000058 , 501028/SN12000026 , 502025/SN12000124 , 502026/SN12000125 , 502424/SN12000034 , 502721/SN12000047 , 503141/SN12000038 , 503142/SN12000037 , 503143/SN12000036 , 503144/SN12000039 , 503380/SN12000044 , 503541/SN12000040 , 504450/SN12000064 , 505077/SN12000048 , 507607/SN12000054 , 507906/SN12000055 , 508342/SN12000057 , 508532/SN12000062 , 508699/SN12000088 , 508783/SN12000108 , 508838/SN12000061 , 509062/SN12000107 , 509633/SN12000069 , 509640/SN12000071 , 510607/SN12000072 , 512160/SN12000077 , 512887/SN12000085 , 512888/SN12000086 , 512890/SN12000087 , 512892/SN12000082 , 513477/SN12000080 , 513478/SN12000081 , 513848/SN12000084 , 514103/SN12000092 , 514104/SN12000091 , 514461/SN12000090 , 514462/SN12000089 , 516891/SN12000110 , 516896/SN12000111 , 518135/SN12000118 , 518342/SN12000119 , 518343/SN12000120 , 518344/SN12000121 , 518345/SN12000122 , 518346/SN12000123 , 519326/SN13000005 , 519387/SN13000012 , 519388/SN13000006 , 519434/SN13000014 , 519506/SN13000011 , 519511/SN13000010 , 519598/SN13000118 , 519599/SN13000119 , 519600/SN13000120 , 519762/SN13000018 , 519763/SN13000013 , 520251/SN13000016 , 520252/SN13000027 , 520253/SN13000017 , 520254/SN13000019 , 520255/SN13000020 , 520256/SN13000021 , 520413/SN13000023 , 520414/SN13000025 , 520415/SN13000026 , 520416/SN13000031 , 520417/SN13000033 , 520418/SN13000030 , 520422/SN13000028 , 522633/SN13000035 , 522944/SN13000037 , 523279/SN13000042 , 523349/SN13000043 , 13000067,  506626/SN12000051,  497570/SN11000066,  509718/SN12000068,  494941/SN11000052,  500740/SN12000028,  500739/SN12000027,  SN11000007 , SN13000059 , SN13000059 , SN13000060 , SN13000061 , SN13000069 , SN13000072 , SN13000073 , SN13000074 , SN13000080 , SN13000082 , SN13000083 , SN13000084 , SN13000087 , SN13000089 , SN13000091 , SN13000095 , SN13000096 , SN13000097 , SN13000098 , SN13000099 , SN13000100 , SN13000101 , SN13000102 , SN13000103 , SN13000104 , SN13000106 , SN13000107 , SN13000112 , SN13000113 , SN13000125 , SN13000146 , SN13000147 , SN13000148 , SN13000149 , SN13000153 , SN13000154 , SN13000157 , SN13000160 , SN13000164 , SN13000170 , SN13000174 , SN13000176 , SN13000179 , SN13000180 , SN13000181 , SN13000182 , SN13000183 , SN13000185 , SN13000206 , SN14000061 , SN14000096 , SN14000097 , SN14000098 , SN14000099 , SN14000100
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI)
  • Description du dispositif
    MobileDiagnost wDR motorized portable diagnostic X-ray systems.
  • Manufacturer
    Sedecal S.A.

Manufacturer

Sedecal S.A.