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A manufacturing error resulted in out of specification R3 Acetabular Shells
The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
Potential for discrepant patient results due to a potential for the primary sample tube to be diluted. In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.
In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.
The FlexLab Centrifuge Module loading algorithm may lead to unbalanced loads which could damage the centrifuge.
Observed an internal repetitive software glitch in ImmersiveView.
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
During an FDA audit, it was discovered that the product was not properly registered with FDA.