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Terminated

MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities. 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.

FDA Recall Z-0586-2016 · Posted 2016-01-11

Recall StatusTerminated
Product CodeBTL
Date Initiated2015-11-19
Date Terminated2019-04-12
Product Quantity83 units

Reason for Recall

Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled.

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution: US distribution in state of: Virginia and to the country of: Singapore.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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