Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0587-2016Class I

MOVES System Lithium Polymer Batteries The MOVES System is a portable computer controlled electrically...

Thornhill Research Inc / initiated 2015-11-19 / Terminated / root cause: design

Thornhill Research Inc began a recall of MOVES System Lithium Polymer Batteries The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to... on . FDA classified it as Class I and gives the reason as "Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0587-2016
Classification
Class I
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Thornhill Research Inc
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.
Product code
BTL Ventilator, Emergency, Powered (Resuscitator)
Reason for recall
Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled.
Root cause tag
design
FDA 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 in commerce
178 units
Distribution
Worldwide Distribution: US distribution in state of: Virginia and to the country of: Singapore.
Product codes and 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, MB201307007, MB201307008, MB201307009, MB201307010, MB201308001, MB201308002, MB201308003, MB201308004, MB201308005, MB201308006, MB201308007, MB201308008, MB201308010, MB201308011, MB201308012, MB201308013, MB201308014, MB201308015, MB201208017, MB201208018, MB201308047, MB201308048, MB201308049, MB201308050, MB201308051, MB201308052, MB201308053, MB201308054, MB201308055, MB201308056, MB201308057, MB201308058, MB201308059, MB201308060, MB201309001, MB201309002, MB201309003, MB201309004, MB201309006, MB201309007, MB201309008, MB201309009, MB201309010, MB201309011, MB201309012, MB201309013, MB201309014, MB201309015, MB201309016, MB201309017, MB201309019, MB201309020, MB201309021, MB201309022, MB201310009, MB201310010, MB201310011, MB201310012, MB201310013, MB201310014, MB201310015, MB201310016, MB201310017, MB201310018, MB201310019, MB201310020, MB201312003, MB201312004, MB201312005, MB201312006, MB201312007, MB201312008, MB201312009, MB201312010, MB201312011, MB201312012, MB201312013, MB201312014, MB201312015, MB201312016, MB201312017, MB201312018, MB201312019, MB201312020, MB201312021, MB201312022

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0587-2016
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0586-2016Class ITerminatedVoluntary: Firm initiated
Z-0587-2016Class ITerminatedVoluntary: Firm initiated