The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Thornhill Research Inc. MOVES Ventilator System
- Product Code Information
- Manufacturing dates: September 10, 2012 to January 29, 2014
- Distribution Dates: November 5, 2012 to February 7, 2014
- Devices Recalled in the U.S.: 261 units were distributed to health care facilities in Virginia
Device Use: The MOVES Ventilator System is a portable emergency transport ventilator that provides breathing support for adults patients. The primary users of this device are medical doctors
Reason for Recall: Thornhill Research Inc. is recalling the MOVES ventilator system 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.
Who may be Affected:
- Health care providers using the MOVES Ventilator System
- Patients who may be given breathing support with an emergency transport ventilators
What to Do: Thornhill Research Inc. sent a Recall Notification letter via email to affected customers on December 15, 2015.
- The letter provided instructions for performing a functionality test on these products.
- Customers were instructed to inform Thornhill of the test results. If the device is not functioning, Thornhill provided instructions for returning it to the firm for repair.
Contact Information: Customers with questions should call Thornhill Research Inc. at: 416-597-1325.
Date Recall Initiated: November 19, 2015
How do I report a problem?:
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.