Recalling Firm / Manufacturer

Newport Medical Instruments Inc

Product

Newport HT50 Ventilator (all Models)

Code Information

All models, all serial numbers

Reason of Recall

Battery Life: With use over time, the internal battery begins losing its ability to hold a charge resulting in shortened ventilator operation time. Specifically, Newport has received a number of reports concerning the internal battery not lasting as long as expected followed by ventilator shut down with less advance warning than when the battery was new.

Date Recall Initiated

July 31, 2007

Action

An Important Medical Device Correction Letter was issued on September 14, 2007 as a short term fix. The firm has submitted a long term correction as a supplement to its 510 K which is pending review by FDA. Firm Initiated recall is ongoing.

Contact

Saudi Healthcare Services Company
Jeddah
(02) 6534455

Source of Information

U.S. FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.