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.
| Date | Jan 11, 2016 (initiated Nov 19, 2015) |
| Status | Terminated |
| Reason | Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled. |
| Root cause | Component design/selection |
| Action | Thornhill 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. |
| Quantity | 178 units |
| Distribution | Worldwide Distribution: US distribution in state of: Virginia and to the country of: Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093261 | MOVES Thornhill Research, Inc., Mar 26, 2010 |