CanadaCentricity Enterprise Archive (models EA 8.0 and EA 4.0) and Centricity PACS Workstation software (catalog numbers 00840682104807 and 00840682145572) from GE Healthcare are affected; serial/lot numbers exceed 10 digits—contact the manufacturer for specifics. They were recalled because historical imaging data migrated from a legacy system may become incorrectly associated with a different patient, causing studies or images to display under the wrong patient record and potentially leading to misdiagnosis or delayed care. Contact the manufacturer if you require additional information.
What's being recalled
Companies: GE Healthcare IITS USA Corp Also Doing Business As GE Healthcare, 500 W. Monroe Street, Chicago, Illinois, United States, 60661.
How to identify it
Affected products: Centricity™ Enterprise Archive; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: EA 8.0
Affected products: Centricity™ Enterprise Archive; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: EA 4.0
Affected products: Centricity™ PACS Workstation - Software; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00840682104807
Affected products: Centricity™ PACS Workstation - Software; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00840682145572
The hazard
GE Healthcare has become aware that, under certain conditions, historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
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)