A recall issued by Thornhill Research over its MOVES Ventilator System has been designated as Class I by the U.S. Food and Drug Administration (FDA). Class I recalls are the most serious type of recall; the label indicates that exposure to the recalled device could lead to serious injury or death. According to the recall notice, Thornhill recalled the MOVES Ventilator System due to a battery problem that may prevent the ventilator from working when needed.
The MOVES Ventilator System is used to help adult patients breathe. The portable emergency transport system is mostly used by physicians. According to the FDA notification, the recalled units were manufactured between September 10, 2012 and January 29, 2014 and distributed between November 5, 2012 and February 7, 2014. The recall affects 261 units distributed to health care facilities in Virginia.
The recall was issued because “excess glue on the battery connectors may prevent the battery from powering the device after the battery is stored. This issue may prevent the ventilator from providing patient breathing support and could cause patient injury or death.” the FDA notification states. The MOVES Ventilator is often used on patients who need breathing support during an emergency transport.
Customers were notified of the issue in a December 15, 2015 Recall Notification email letter, which also contained instructions for performing a functionality test.