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U.S. Department of Health and Human Services

Class 1 Device Recall Portable Life Support System

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  Class 1 Device Recall Portable Life Support System see related information
Date Initiated by Firm November 19, 2015
Date Posted January 11, 2016
Recall Status1 Terminated 3 on April 12, 2019
Recall Number Z-0587-2016
Recall Event ID 72867
510(K)Number K093261  
Product Classification Ventilator, emergency, powered (resuscitator) - Product Code BTL
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.
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
Recalling Firm/
Manufacturer		 Thornhill Research Inc
210 Dundas St W Suite 200
Toronto Canada
For Additional Information Contact Kipton Lade
1-416-597-1325
Manufacturer Reason
for Recall		 Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BTL and Original Applicant = THORNHILL RESEARCH INC
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