Flight Medical, Ltd.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Flight Medical, Ltd. makes
Flight Medical, Ltd. manufactures the FLIGHT 60 VENTILATOR (Model F-60), a mechanical ventilator designed for use in medical settings to assist or replace spontaneous breathing.
The FLIGHT 60 VENTILATOR is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Flight 60 Ventilator, Model F-60 Ref K100753
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Flight Medical, Ltd., initiated on 2011-08-10. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 10 Aug 2011 Z-1041-2012 Unclassified (pre-2012) Terminated The recall was initiated because Flight Medical Innovations Ltd. has identified a problem may occur when contact between an exposed unused wire and the grounding wire occurs. If this contact occurs the ventilator may reset and switch off.
Frequently asked questions
How many devices does Flight Medical, Ltd. have in the registry?
The registry currently lists 1 device for Flight Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Flight Medical, Ltd.'s devices?
Among its 1 most recently registered device, Flight Medical, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Flight Medical, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Flight Medical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Flight Medical, Ltd.?
FDA recall records list 1 recall initiated by Flight Medical, Ltd., the most recent initiated on 2011-08-10. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Flight Medical, Ltd. in the registry?
The most recently registered devices listed for Flight Medical, Ltd. include FLIGHT 60 VENTILATOR, MODEL F-60.