Recall Z-1041-2012 ยท CBK Ventilator, Continuous, Facility Use
Flight Medical Ltd.
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.
| Date | Feb 21, 2012 (initiated Aug 10, 2011) |
| Status | Terminated |
| 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. |
| Root 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- |
| Quantity | 363 total units, all in the US |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |