Events

Rappel de Volcano s5, s5i, CORE and CORE Mobile 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 Volcano 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
    73984
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1813-2016
  • Date de mise en oeuvre de l'événement
    2016-04-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-01-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145824
  • 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
    Catheter, ultrasound, intravascular - Product Code OBJ
  • Cause
    Volcano has become aware of an incompatibility issue between impacted systems and hospital network scans. in specific circumstances, an impacted system will encounter unexpected data from the hospital network and be forced to reboot.
  • Action
    The firm, Philips, sent an "URGENT MEDICAL DEVICE FIELD CORRECTIVE ACTION" letter dated 4/25/2016 to its customers beginning April 29, 2016 which include a technical service bulletin to explain how to assure the incompatibility issue does not affect system performance. The customers were instructed to do the following: -If you have an Impacted System but it is not connected to a network, this issue does not affect your system. Additionally, if network scans are not performed, this issue does not affect your system. -If you have an Impacted System that is connected to a network and staff performs network scans while the Impacted System is in operation, this issue does affect you and the circumstances exist for a manual reboot to occur during an active procedure. To avoid this, the following corrections must promptly be taken: 1. Disconnect your Impacted Systems from the facilities network. If you need to reconnect it while not being used in a procedure, make sure it is disconnected again before starting any procedure; OR 2. Do not permit your staff to perform network scans while the Impacted Systems are in operation. -Please complete, sign, and return the attached form indicating that you received this Field Corrective Action notification via Fax to Volcano Customer Service at (916) 638-8812 or email to CS@volcanocorp.com. If you have any questions, please call (800) 228-4728, option 5.

Device

Volcano s5, s5i, CORE and CORE Mobile systems
  • Modèle / numéro de série
    Systems with software version 3.2.x, 3.3,and 3.4 and v3.4 software kits. Product Codes: 807300001-807300001-R, 804200001-E, 807300001-E,807400001, 804200001, 806300001,1807400001,804200015, 804200001-M, 807400001-R, 07300001-M, 807300015-J, 804200014-R,804200014, 807400010, 804200001-R, 806300001-R, 807300015-RF,804200001-E, 806300001-R, 806300026, 807300001-R, 806300007,807300015  Serial Numbers: 101951631001,05207007001,101950286001,05207131001,05627, 05206042001, 0520641200, 1101950547001, 101950181001, 05206363001, 101950277001, 101951298001, 05207035001,05339,101950590001, 05206734001,101950229001,05206884001,102120770001,101950240001, 101950843001,105206471001,101950244001,05206115001,05206046001 05660,05036,06804119001,05205021001,06802011001,101950285001 101950192001 06801062001 102500002001 05208721001 05208168001 101950619001 05320041001 101951238001 05206001001 05206188001 101951628001 05208457001 05028 101950239001 977299 GREG RAUCH 6942 E. HUNTING HOLLOW CT 101950614001 101951308001 05206726001 05208267001 101950671001 05208316001 05014 06802001001 06802003001 05208369001 05206949001 05208371001 06802004001 06802004001 101950678001 05206033001 06802202001 06802893001 101950045001 05303126001 06802035001 06801009001 101950178001 06801004001 06801019001 06801018001 06801063001 05304085001 05208185001 05304027001 06801731001 101950118001 101951303001 05206414001 05208001001 05031 05206441001 05656 05206054001 05206070001 06802200001 05206824001 05304084001 101950618001 05667 05208328001 101951633001 101950617001 05206062001 06801413001 101950204001 06801166001 102120066001 102120067001 102120003001 102120052001 06804578001 101950795001 102120939001 05343 05432 06801371001 06803918001 05530 05206682001 05206216001 05304091001 101951620001 05206063001 06801233001 101950084001 101950082001 05206479001 05682 101950235001 9775006804470001 05208621001 05304099001 102120618001 102120916001 06804520001 05206595001 05304102001 05206787001 9705533 977102120835001 05057 05573 05209172001 05234 05621 05392 05769 06802373001 05206821001 05208306001 06801764001 06804600001 101950304001 102120834001 05487 06801122001 06804206001 05274 05082 05429 05658 05198 05522 05523 05304088001 06801320001 06801724001 06801498001 05206623001 06802367001 05208127001 5006802178001 05320037001 05208128001 06804052001 06802870001 05208548001 06801782001 05588 05603 05572 06801035001 06801222001 06801324001 06801226001 06801518001 06802339001 06802194001 05206803001 06801137001 05206662001 102121025001 05571 05043 05304252001 05502 05562 05524 05498 05633 05206219001 06801769001 06801768001 06804546001 101950288001 102120502001 102120836001 05304255001 06801327001 06801055001 06801739001 06801325001 06802405001 06803928001 05593 06801108001 06802232001 05335 05409 06801463001 06801453001 06804692001 101950571001 102320013001 101950769001 101950770001 101950780001 101950755001 101950782001 101950758001 101950784001 101950756001 101950768001 101950757001 101950783001 101950776001 101950781001 101950759001 101951297001 101951288001 101951032001 101951054001 101951027001 101951055001 101951051001 101951053001 06804375001 102160266001 101951025001 05508 05267 05699 05025 05760 05272 05410 05407 05649 05320042001 05206943001 05206994001 052PLT02001 05207095001 101950579001 05208068001 052PLT03001 101950215001 05206067001 05206766001 052208148001 06801097001 06801460001 06801091001 06801105001 06801300001 06801135001 06801192001 06801281001 06801133001 06802335001 102120076001 102120075001 06801049001 102120068001 06804318001 06802747001 06802920001 102120226001 101951191001 05206917001 05209026001 101951559001 05032 05208561001 05206825001 101950740001 977101951536001 05175 102120272001 06801075001 05313 05271 8888 06804239001 06801208001 05208148001 05208163001 05208603001 06804382001 102120270001 101950674001 05304012001 06804385001 06804383001 05054 05206069001 06802164001 05206764001 05206757001 05207024001 05206850001 05207038001 05206745001 06804132001 06804240001 06803996001 06804138001 05208507001 05207079001 06804313001 102120511001 102120512001 102120255001 102120638001 05626 05689 05303080001 06801494001 05535 05208385001 102120308001 05208633001 V10195005001 05208752001 05208544001 102050068001 102120062001 102120004001 05304256001 102121035001 102121033001 102121020001 05625 9999 06801235001 06801493001 06801353001 06802048001 06802979001 06802981001 06802982001 06802980001
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and countries of: Japan, South Africa, Germany, Sweden, Belgium, France, Italy, Spain, India, Russian Federation, Hungary, Turkey, Poland, Portugal, Costa Rica, Finland, Great Britain, Croatia, India, Chile, Thailand, Mauritius, Iraq, Denmark, Norway, Ireland, Netherlands, Bulgaria, Czech Republic, Luxembourg, UAE, Austria, Poland, Pakistan, Sri Lanka, Kazakhstan, Slovakia, Saudi Arabia, Unite Arab Emirates, Egypt., Jordan, Kuwait, Lebanon, Bulgaria, Romania, Latvia, Lithuania, Bosnia and Herzegovina, Greece, Malta, Cyprus, Romania, Tunisia, Kenya, Algeria, Israel, Jordan, Hong Kong, Republic of Korea, Malaysia, New Zealand, Venezuela, Brazil, Philippines, Australia, Taiwan, Peru, Singapore, Panama, Mexico, Argentina, Costa Rica, Dominican Republic, China, and Paraguay,
  • Description du dispositif
    Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. || Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.
  • Manufacturer
    Volcano Corporation

Manufacturer

Volcano Corporation
  • Adresse du fabricant
    Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA