All Recalls

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

Failed Dissolution Specifications

Failed Dissolution Specifications: results slightly under spec at at 9-months.

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

Products not sterilized, sterility cannot be confirmed

Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

Products not sterilized, sterility cannot be confirmed

Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.

Products not sterilized, sterility cannot be confirmed

Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in delays in medication access, and potential data loss.

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components

The sterile blister packaging may be damaged, and sterility may be compromised.

Potential packaging breaches of inner blister and outer sterile blister.

Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

The sterile blister packaging may be damaged, and sterility may be compromised.

The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.