Recall Z-0587-2016
Thornhill Research Inc · initiated November 19, 2015
Class I – dangerous or defective products that could cause serious health problems or death
Product
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.
Codes / lots: MB201205001, MB201205002, MB201205003, MB201205004, MB201205005, MB201205006, MB201205007, MB201205008, MB201205009, MB201205010, MB201208001, MB201208002, MB201208003, MB201208004, MB201212001, MB201212002, MB201212003, MB201212004, MB201212005, MB201212006, MB201212007, MB201212008, MB201212009, MB201212010, MB201212011, MB201212012, MB201208019, MB201208020, MB201308021, MB201308022, MB201308023, MB201308024, MB201308025, MB201308026, MB201308027, MB201308028, MB201308029, MB201308031, MB201308032, MB201308033, MB201308034, MB201308035, MB201308036, MB201308038, MB201308039, MB201308040, MB201308041, MB201308042, MB201308043, MB201308044, MB201308045, MB201308046, MB201309023, MB201309024, MB201309025, MB201309026, MB201309027, MB201309028, MB201309029, MB201309030, MB201309031, MB201309032, MB201309033, MB201309034, MB201309035, MB201309036, MB201309037, MB201309038, MB201309039, MB201309040, MB201310001, MB201310002, MB201310003, MB201310004, MB201310005, MB201310006, MB201310007, MB201310008, MB201212013, MB201212014, MB201212015, MB201212016, MB201212017, MB201212018, MB201212019, MB201212020, MB201307001, MB201307002, MB201307003, MB201307004, MB201307005, MB201307006…
Reason for recall
Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled.
FDA-determined cause: Component design/selection
Action taken
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.
Details
- Recall number
- Z-0587-2016
- Initiated
- November 19, 2015
- Posted by FDA
- January 11, 2016
- Terminated
- April 12, 2019
- Product code
- BTL – Ventilator, Emergency, Powered (Resuscitator)
- Quantity
- 178 units
- Distribution
- Worldwide Distribution: US distribution in state of: Virginia and to the country of: Singapore.
- Recalling firm
- Thornhill Research Inc, Toronto
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0586-2016 Class I | MOVES System, an emergency ventilator with suction, oxygen concentrator and…Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled. | 11/19/2015Terminated |