Device recall: MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring…
Class I FDA enforcement event 72867. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled.
Class I, in the words of FDA
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
Thornhill Research Inc started this device recall on 19 Nov 2015. The firm address in the FDA record is in Toronto. FDA put the recall in Class I. FDA event 72867 has 2 product records. The first FDA enforcement report date is 20 Jan 2016. The record gives the status Terminated, with the termination date 12 Apr 2019.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution: US distribution in state of: Virginia and to the country of: Singapore.
Recalling firm
Thornhill Research Inc, Toronto, N/A, Canada.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0586-2016 | 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… | 83 units | Class I | Terminated | 20 Jan 2016 |
| Z-0587-2016 | 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. | 178 units | Class I | Terminated | 20 Jan 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2015
- 1,153
- Share of these events in Class I
- 4%
- Product records in this event
- 2
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-0586-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 72867. https://recallregister.com/fda/i/72867/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution: US distribution in state of: Virginia and to the country of: Singapore.
- What quantity of product is in FDA event 72867?
- The event has 2 product records. The first record gives this quantity:
83 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 4% of the 1,153 device events that started in 2015 are in Class I.