Events

Rappel de Device Recall Ziehm Imaging GmbH

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 Ziehm Imaging 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
    66976
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0566-2014
  • Date de mise en oeuvre de l'événement
    2013-11-21
  • Date de publication de l'événement
    2013-12-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-06-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124376
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Cause
    Engineering change in 2006 resulted in a minor non-conformity of their devices. specifically the emergency switch was changed from a standard component to just an option on the devices.
  • Action
    Ziehm Imaging sent an "URGENT RECALL NOTICE" letter dated November 22, 2013, to all affected customers. The letter identified the products the problem and the action needed to be taken by the customers. Customers were advised and instructed to: Your Model and Serial number can be found on the product label attached to the side of the mobile C-arm Stand. Our records indicate that your facility has one or more of the products listed above that are being used in your facility. Recall of the product was initiated because according to our manufacturing documentation, the referenced device installed at your facility was not equipped with an emergency stopping device for vertical travel of the c-arm imaging assembly. To fully comply with applicable standards the referenced device must be retrofitted with an emergency stopping device identification and label. The issue: According to our manufacturing documentation, the referenced device installed at your facility was not equipped with an emergency stopping device. To fully comply with applicable standards the referenced device must be retrofitted with an emergency stopping device. The manufacturer Ziehm Imaging GmbH advised customers they may continue to operate the affected device with caution until the correction has been carried out on-site. During this time Ziehm Imaging GmbH advises the operator to be aware of the following safety measures which may resolve the possibility of potentially hazardous situations by: " Operating the power-off switch located either on the C-arm Stand top panel or on the monitor cart " Removing the power cable from the wall outlet or, " Activate the push-buttons for reverse vertical movement and keeping the pushbutton pressed until patient /operator is no longer in the risk zone or the device stops Please alert all staff members working with the device to these potential hazardous situations, and familiarize them with all possibilities to resolve the hazardous situation

Device

Device Recall Ziehm Imaging GmbH
  • Modèle / numéro de série
    90842
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.
  • Description du dispositif
    Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. || Mobile Fluoroscopic Imaging
  • Manufacturer
    Ziehm Imaging Inc

Manufacturer

Ziehm Imaging Inc
  • Adresse du fabricant
    Ziehm Imaging Inc, 6280 Hazeltine National Dr, Suite 100, Orlando FL 32822-5114
  • Société-mère du fabricant (2017)
    Aton 2 Gmbh
  • Source
    USFDA