FDA Device

Model 740 and 760 series Ventilators.

Hazard

Capacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss.

What You Should Do

Remedy

Customers of record will be notified by letter sent FEDEX, a simple test instruction will be included to use to test the performance of the backup alarm.

Products

Model 740 and 760 series Ventilators.
Brand
Nellcor Puritan Bennett Inc
UPC
All units ever manufactured. The product may be identified and tracked through serial numbers. This is a tracked device.

Units Affected

13,010 worldwide, 3,948 in USA and territories.