Newport HT50 Ventilator. Model #HT50 H1-B The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs), who require the following general types of ventilatory support.
FDA Recall Z-2295-2011 · Posted 2011-05-26
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Recalling FirmNewport Medical Instruments Inc
Recall StatusTerminated
Product CodeCBK
Date Initiated2009-01-13
Date Terminated2011-06-01
Reason for Recall
The recall was initiated because Newport Medical Instruments confirmed that the Newport HT50 ventilators that were shipped in December 2008 were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery.
Firm Action
Newport Medical Instruments, Inc. sent an FIELD CORRECTION letter dated January 13, 2009, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer.
The Newport HT50 ventilators that were shipped in December 2008, were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery.
The customer were also requested to complete the attached customer REWORK INSTRUCTIONS form and fax it to (714) 427-0489.
If you have any further questions, please call (714) 427-5811 x 344
Root Cause
Other
Distribution Pattern
Worldwide Distribution-- USA including states of OH, VA, WA, WI and country of Turkey.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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