Events

Recall of V240040029 cable

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Flight Medical Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59827
  • Event Risk Class
    Class 1
  • Event Number
    Z-1041-2012
  • Event Initiated Date
    2011-08-10
  • Event Date Posted
    2012-02-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103824
  • Notes / Alerts
    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.
  • Extra notes in the data
    Ventilator, continuous, facility use - Product Code CBK
  • Reason
    The recall was initiated because flight medical innovations ltd. has identified a problem may occur when contact between an exposed unused wire and the grounding wire occurs. if this contact occurs the ventilator may reset and switch off.
  • Action
    Newport Medical Instruments, Inc., the U.S. distributor for Flight Medical Ltd., sent a letter dated August 23, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately discontinue use of the affected product. An Acknowledgement Form was attached to the letter for customers to complete and return via fax at (714) 427-0489 or e-mail to Regulatory@NewportMedical.com. Replacement product will be provided once the form is received. Contact Newport Medical's Technical Service Group at 800-451-3111 ext. 500 for questions regarding this notice. Updated: The firm posted a press release on 02/12/12 Isreal time, notifying customers of update regarding its voluntary recall of remote alarm cable, part number V24-00400-29, used to connect a Newport HT50 mechanical ventilator to a nurse station. The press release notified: The recalled cable may negatively affect Newport HT50 ventilators manufactured prior to 2007. Affected units may shutdown unexpectedly. The FDA has classified this action as a Class I recall. On August 23, 2011, Flight Medical sent an urgent Recall Notice to affected customers through its distributor, Newport Medical Instruments, Inc. (Newport Medical), to stop using the alarm cable immediately and to contact Newport Medical in order to receive an upgraded version of the cable. In the notification letter, the customers were notified of the affected cables and that an upgraded version of the cable would be provided to them free of charge. Customers, including Newport Medical are requested to dispose of the affected cables properly. Instructions to customers: Customer inquiries related to this action should be addressed to Newports Technical Service Group at (800) 4513111, extension 500.

Device

V240040029 cable
  • Model / Serial
    P/N V24-00400-90 Rev. B
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    V24-00400-29 cable, an accessory to the Newport HT50 ventilator. || The V24-00400-29 cable is an accessory to the Newport HT50 ventilator intended to transfer the alarm signal from the ventilator to a nurse remote station.
  • Manufacturer
    Flight Medical Ltd.

Manufacturer

Flight Medical Ltd.
  • Manufacturer Address
    Flight Medical Ltd., 13 Hamelacha Street, Lod Israel
  • Source
    USFDA