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Sterility barrier compromised.
Air may be introduced into this Stent system when used with certain size acessory devices.
adjustment screw may break due to material fatigue
The device is not stable throughout its labeled expiration date.
This device is not approved for sale in the US.
Sterility compromised due to lack of package seal integrity
Increased numbers of lens tears during placement of lens into eye.
mislabeled - product actually Single Valve
A certain sequence of data entries on the keypad could cause the ultrasound medical device to display incorrect transmission power.
The flow meter could malfunction resulting in loss of touchscreen control of the gas system, but the alternate mechanical control will remain operable.
Potential failure to audibly alarm due to speaker hardware component failure.
Mislabeled.
SoftPath Cases with Word Perfect documents that were not signed out in ASCII are printing in GUI as a converted document from Word Perfect to PDF document instead of the current MS Word Document. This affects clients upgrading from ASCII to SoftPath GUI 3.17.7.6 Version. All affected clients have been notified and corrections have been made.