Z-0587-2016 Class I Terminated
FDA device recall Z-0587-2016 was initiated by Thornhill Research Inc on November 19, 2015 and is designated Class I. Reason for recall: Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled. The recall status is terminated (terminated April 12, 2019). Affected quantity: 178 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 20, 2016
- Initiation Date
- November 19, 2015
- Termination Date
- April 12, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 178 units
Product Description
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.
Reason for Recall
Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled.
Distribution Pattern
Worldwide Distribution: US distribution in state of: Virginia and to the country of: Singapore.
Code Information
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