Class 1 Device Recall V240040029 cable

• Date Initiated by Firm: August 10, 2011
• Date Posted: February 21, 2012
• Recall Status: Terminated on May 21, 2012
• Recall Number: Z-1041-2012
• Recall Event ID: 59827
• 510(K)Number: K082724 K992133
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: 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.
• Code Information: P/N V24-00400-90 Rev. B
• Recalling Firm/ Manufacturer: Flight Medical Ltd.; 13 Hamelacha Street; Lod Israel
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 363 total units, all in the US
• Distribution: Nationwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CBK and Original Applicant = NEWPORT MEDICAL INSTRUMENTS, INC.