CanadaWhat's being recalled
Companies: Steris Corporation, 2720 Gunter Park East, Montgomery, Alabama, United States, 36109.
How to identify it
Affected products: Hexavue Focus Integrated System; Lot or serial number: SN: RL26028062; Model or catalogue number: XEHFBU1
Affected products: Hexavue Focus Integrated System; Lot or serial number: SN: RL26063007; Model or catalogue number: XEHFBU1
The hazard
A software issue may result in unintended mismatch of patient information on manually printed images. During an active procedure, a user may manually select a different patient record from the “Patient Cases” menu and subsequently manually print images (“Manual Print Workflow”). In this specific Manual Print Workflow, the printed output may display patient identifying information from the selected patient record rather than the active procedure, including patient name, date of birth and medical record number (MRN).The image displayed is the image intended for the procedure; however, the printed image may contain incorrect patient identifiers. Auto-Print functionality is not impacted.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States