Recall Z-0586-2016— Thornhill Research Inc
Class I · Terminated
Class I FDA medical device recall by Thornhill Research Inc, initiated 2015-11-19, terminated 2019-04-12. It names one FDA 510(k) clearance: K093261. Product: 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.. Reason: Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled..
- Recalling firm
- Thornhill Research Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-11-19
- Terminated
- 2019-04-12
- Firm location
- Toronto, N/A, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.