Mizuho recalls OSI Modular Table Systems
Due to reports of patient injuries related to the Mizuho OSI Modular Table Systems, the FDA has notified healthcare professionals of a Class I recall of the product. The systems are used for patient positioning during orthopedic trauma, thoracic, and spinal surgery procedures.
According to the recall notice, the incorrect removal of the “T-pins” that support the bottom base may result in unexpected movement or tilting of the table, which may cause patient falls during surgery—possible resulting in serious injury or death.
Mizuho issued a Field Advisory Notice on July 29, to hospital risk management, operating room directors, technicians, physicians, nurses and other personnel notifying them of the problem and providing recommendations for safe use. Although the FDA agrees with the problems identified by Mizuho, the agency is concerned there may be unidentified factors contributing the reports.
Class I recalls are the most serious type of recall. The FDA has encouraged healthcare professionals and consumers to report any adverse events related to the product.
According to the recall notice, the incorrect removal of the “T-pins” that support the bottom base may result in unexpected movement or tilting of the table, which may cause patient falls during surgery—possible resulting in serious injury or death.
Mizuho issued a Field Advisory Notice on July 29, to hospital risk management, operating room directors, technicians, physicians, nurses and other personnel notifying them of the problem and providing recommendations for safe use. Although the FDA agrees with the problems identified by Mizuho, the agency is concerned there may be unidentified factors contributing the reports.
Class I recalls are the most serious type of recall. The FDA has encouraged healthcare professionals and consumers to report any adverse events related to the product.