Mizuho OSI Modular Table Systems: Class I Recall - Reports of Patient Injury
MedSun: Newsletter #67, December 2011
FDA MedWatch Safety Alert
FDA notified health professionals of a Class I Recall of Mizuho OSI Modular Table Systems because of reports of patient injury related incidents. The incorrect removal of the T-pins that support the bottom base, instead of the T-pins that support the top, may result in patients falling to the floor. Another potential concern is unexpected movement/tilting of the table which may result in unanticipated movement and/or patient falls during surgery. Patient falls or unanticipated movement may result in serious injury or death. Mizuho issued a field advisory notice providing warnings and recommendations for safe use of the Mizuho OSI Modular Table Systems including performing a verification count of all the T-pins to confirm the stability of the table top.
FDA MedWatch Safety Alert. Mizuho OSI Modular Table Systems: Class I Recall - Reports of Patient Injury. November 9, 2011.