Events

Rappel de Device Recall Philips BV Pulsera

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 Medical Systems North America Co. Phillips.

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
    57611
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1605-2011
  • Date de mise en oeuvre de l'événement
    2010-12-14
  • Date de publication de l'événement
    2011-03-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96794
  • 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 IXL
  • Cause
    The fixing strap of the belt holding the cbx laser to the image intensifier may be detached during a procedure when used with the bv libra and the bv pulsera/endura systems.
  • Action
    On 01/06/11, Philips sent an URGENT Device Correction Notice, dated 01/05/2011, to their consignees. The consignees were informed that the fixing strap of the Laser Aiming Device Image Intensifier may inadvertently detach when used with BV Libra, BV Endura Rel. 2, and BV Pulsera Rel 2.3 Mobile X-Ray systems. Specifically the draw latch of the fixing strap holding the CBX Laser to the Image Intensified can be accidentally released during a procedure when used with the above Mobile X-Ray systems. While waiting for Philips to implement their corrective action, the consignees are advised to fix the closed latch body of the draw latch to the metal band using a Tie Wrap. Without securing the latch with a Tie Wrap, the device should not be used. The consignees can contact Philips Call Center at 1-800-722-9377, select 5, and reference FCO 71800035 with any questions about this recall.

Device

Device Recall Philips BV Pulsera
  • Modèle / numéro de série
    Site Numbers:  541558, 543462, 543465, 546516, 546531, 546786, 548972, 549275, 549674, 551422, 551444, 551536, 552246, 552452, 552642, 553590, 554473, 554778, 555172, 555727, 555734, 556193, 556206, 556207, 556887, 556920, 557242, 557528, 557570, 557711, 558004, 558232, 558418, 558531, 558632, 558698, 558867, 558925, 558966, 558967, 559322, 559533, 559655, 559658, 559679, 718093, 718101, 41443721, 41444449, 41444577, 41445484, 41445534, 41445599, 41445718, 41445794, 41445895, 41446243, 41446285, 41566245, 41577033, 41587498, 41611719, 41620935, 41620966, 41621991, 41630562, 41645797, 41657683, 41725782, 41748088, 41748089, 41757996, 41780384, 41781354, 41793882, 41885442, 41898013, 41936644, 41938193, 41957602, 41980506, 41986348, 41986353, 41986793, 41987067, 42028669, 42057341, 42182116, 42451705, 42454796, 42474222, 42474223, 42474572, 42474590, 42474663, 42474665, 42474666, 42485796, 42573106, 42573206, 42573399, 42602299, 42616997, 42624941, 42638526, 42657622, 42672459, 42673598, 42677649, 42678321, 42678333, 42678370, 42792818, 42792938, 42859118, 42861795, 42865605, 42869019, 42878225, 42878264, 42878386, 42878440, 42879150, 42879151, 42879230, 42879779, 42891959, 42943097, 42967767, 42968938, 43121942, 43188697, 43246451, 43443832, 43444160, 43444432, 43627105, 43670825, 43708894, 43721186, 43721760, 43721768, 43901634, 43901635, 43972187, 44038499, 44066851, 44235029, 44267704, 44280799, 44330157, 44331403, 44468017, 44489300, 44618133, 45003856, 45030262, 45142308, 45147848, 45147983, 45149689, 45167263, 45168542, 45170408, 45298834, 45303038, 45354311, 45419191, 45428659, 45428664, 45567407, 45586672, 45613075, 45632498, 45641330, 45641331, 47171051, 47349848, 47403000, 47405559, 47420473, 47420474, 47480674, 47539379, 49025829, 49316313, 49368038, 49521186, 49580142, 49753197, 49755484, 49755485, 49875328, 50093136, 50103844, 50110372, 50230731, 50264654, 50305994, 50467164, 50498513, 50829949, 50829955, 51232777, 51240352, 51240364, 51240371, 51240383, 51240386, 51674316, 51702012, 51834968, 51836826, and 51836851.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Washington, DC.
  • Description du dispositif
    Philips BV Pulsera, Rel. 2.3, 718095. || Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Adresse du fabricant
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA