V24-00400-29 cable, an accessory to the Newport HT50 ventilator. The V24-00400-29 cable is an accessory to the Newport H

FDA device recall Z-1041-2012 · posted 2012-02-21 · Terminated

Recall details

Recalling firm

Flight Medical Ltd.

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

CBK

Quantity affected

363 total units, all in the US

Distribution

Nationwide Distribution.

Date initiated

2011-08-10

Date posted

2012-02-21

Date terminated

2012-05-21

Location

Lod, Israel

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