STERRAD 200 System Carriage 의 안전성 경고

Safety alert

2013-03-26

2013-03-26

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130326.html

Medical device safety alert: advanced sterilization productssterrad200 systemcarriage medical device manufacturer, advanced sterilization products (a johnson & johnson company) has issued a field safety notice concerning sterrad200 systemcarriage(part number10208). advanced sterilization products recently determined that the push bar located on the sterrad 200 system carriage can potentially become dislodged when an excessive load is applied. the push bar handle is intended to push and maneuver the carriage for loading and unloading of instrumentation into the sterrad 200 system chamber. the push bar is not intended to withstand the weight of the carriage and instrument load by lifting vertically on the handle. in the event that the push bar is used to lift the carriage vertically, the push bar has the potential to dislodge from the carriage. the manufacturer advises users to examine the sterrad 200 system carriage push bar and ensure that it is securely connected to the carriage frame. if the push bar appears to have a loose connection with the carriage, do not attempt to repair the push bar and contact the local representative. if the connection is intact, users can continue to use the carriage per the sterrad 200 system user’s guide and re-inspect it periodically. the manufacturer also reminds users not to use the push bar to lift the carriage vertically when docking the carriage to the sterrad 200 system and do not force the connection if the sterrad 200 carriage is not docking properly to the sterrad 200 system docking station.In the event that the push bar becomes dislodged from the carriage during use, do not attempt to reassemble the push bar into the carriage. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 26 march 2013.