Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning GE OEC Medical Systems Inc. GE OEC Elite and OEC Mobile Elite C-Arms General Surgical Platform Non-Motorized Cooling [Model or catalog number: OEC ELITE, OEC 9900 ELITE; Lot or serial number: More than 10 numbers] [HKMD No.: 180175].
According to Health Canada, the 9-inch image intensifier for the impacted systems can become detached if the systems encounter a large impact force when moved.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/ge-oec-elite
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 Jun 2023