Agency classClass IOur severity:Severe FDA (Devices)·Z-0587-2016·Announced 2016-01-20

Thornhill Research Recalls MOVES System Lithium Polymer Batteries

Thornhill Research Inc is recalling 178 MOVES System Lithium Polymer Batteries because they 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 178 units of 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 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 batteries were distributed worldwide, including in the state of Virginia and the country of Singapore. Consumers and healthcare facilities should check their inventory for the specific lot codes listed in the official recall notice and contact Thornhill Research Inc for instructions on how to proceed.

The recalled product

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.
Manufacturer: Thornhill Research Inc
Category: Medical Device — Ventilator
Hazard: device-malfunction
battery-defect
Affected units: 178

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)

MB201205001
MB201205002
MB201205003
MB201205004
MB201205005
MB201205006
MB201205007
MB201205008
MB201205009
MB201205010
MB201208001
MB201208002
MB201208003
MB201208004
MB201212001
MB201212002
MB201212003
MB201212004
MB201212005
MB201212006

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 Emergency Ventilators Due to Battery Defects
FDA (Devices) · 2016-01-20

Same hazard · device malfunction