Agency classClass IOur severity:Severe FDA (Devices)·Z-0586-2016·Announced 2016-01-20

Thornhill Research Recalls MOVES Emergency Ventilators Due to Battery Defects

Thornhill Research Inc. is recalling 83 MOVES System emergency ventilators because the batteries may become unresponsive after storage and remain perpetually enabled.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled."

Plain-English summary

Thornhill Research Inc. is recalling 83 units of the MOVES System, a portable emergency ventilator with suction, oxygen concentrator, and multi-parameter patient monitoring capabilities. The device is intended to provide continuous or intermittent ventilatory support for adults who require ventilation.

The recall was initiated because the batteries were found to be unresponsive after storage and not recognized by the main device. Additionally, the batteries are described as being perpetually enabled. The affected units were distributed worldwide, with specific US distribution in Virginia and distribution to Singapore.

Consumers should contact Thornhill Research Inc. for instructions on how to resolve the issue with the affected units.

The recalled product

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…
Manufacturer: Thornhill Research Inc
Category: Medical Device — Ventilators
Hazard: battery-defect
device-malfunction
Affected units: 83

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

MS201205001
MS201205002
MS201205003
MS201205004
MS201205005
MS201212001
MS201212002
MS201212003
MS201212004
MS201212005
MS201212006
MS201212007
MS201212008
MS201212009
MS201212010
MS201212011
MS201212012
MS201212013
MS201212024
MS201212025

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Thornhill Research Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Thornhill Research Inc

See all →

Severe
Thornhill Research Recalls MOVES System Lithium Polymer Batteries
FDA (Devices) · 2016-01-20

Same hazard · battery defect