Class I - Dangerous
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Caire
Class I - Dangerous
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Class I - Dangerous
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Class I - Dangerous
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Class I - Dangerous
An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
Class I - Dangerous
An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
Class I - Dangerous
An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
Class I - Dangerous
An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
Class I - Dangerous
The device was not cleared for U.S. distribution.
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Class I - Dangerous
There is an electronics control issue that causes the unit to not power on with battery power only.