Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup Lookup (HULU). Use of an incorrect hookup connection and/or parameter set may prevent an endoscope from being properly disinfected, which may present a risk of patient contamination or infection
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)