Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Visual-ICE MRI Mobile Connection Panel (MCP) [Material Number (UPN): FPRCH7100; Serial Number: VM032; GTIN: 00859019006332].
The manufacturer is initiating a correction on one Visual-ICE MRI MCP unit with an incorrectly installed base. This makes the connections to the MCP front facing, exacerbating the potential for a tripping hazard. The most serious injury reasonably foreseeable to occur would be to the user during set-up of the system, if the user were to trip over the harness. No patient injury is reasonably foreseeable from this issue. This correction affects only the UPN and serial number listed.
According to the local supplier, the affected product is not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 September 2020