Medical device manufacturer, Getinge, has issued a medical device safety alert concerning its mobile OR-Table MEERA, YUNO and YUNO II [Affected Article Number in Hong Kong: 143301B0, 143302B0 and 710001B0].
As part of the manufacturer's post market surveillance, cases with pulled-out plastic sockets (IEC 60320-1) of mobile OR-Tables MEERA, YUNO and YUNO II were reported. Electric parts and/or wires were exposed. If the mains cable (power cord) is still connected to the mains socket (power source), there is a risk of electric shock to users or third parties when touching exposed, electronic components. Six cases have been reported to the manufacturer where the users received an electric shock. No permanent injury was reported to the manufacturer in any of these cases.
According to the manufacturer, until all corrective actions have been accomplished, a visual and functional check is required to be performed by a trained person before operation. Furthermore, the information in the Instructions For Use regarding connection to and disconnecting from the mains socket (power source) should be observed as a matter of urgency.
If the plastic socket of the cold-device plug is pulled out, users should not try to put it back into the housing. If electronic parts or wires are exposed, users should not touch them. Affected users should disconnect/detach the cable from the main socket and call the in-house technical service and arrange the repair of the table.
A technical solution correcting this issue has been developed. The manufacturer will contact affected users to schedule the update of the affected products.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 11 September 2020