ClearanceBrief
Recall Z-0587-2016 ยท BTL Ventilator, Emergency, Powered (Resuscitator)

Thornhill Research Inc

MOVES System Lithium Polymer Batteries The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation.

DateJan 11, 2016 (initiated Nov 19, 2015)
StatusTerminated
ReasonBatteries found unresponsive after storage, not recognized by main device, and are perpetually enabled.
Root causeComponent design/selection
ActionThornhill Research sent a Recall Notification letter dated December 15, 2015 to affected customers. The letter identified the affected products, problem and actions to be taken. Customers were instructed to update their device software. For questions customers were instructed to call 416-597-1325.
Quantity178 units
DistributionWorldwide Distribution: US distribution in state of: Virginia and to the country of: Singapore.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K093261MOVES
Thornhill Research, Inc., Mar 26, 2010