  |
Mizuho OSI Modular Table Systems: Class I Recall - Reports of Patient Injury
AUDIENCE: Risk Managers, Surgery, Orthopedics
ISSUE: 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.
BACKGROUND: Mizuho OSI Modular Table Systems are used for patient positioning during a diverse set of orthopedic trauma, thoracic, and spinal surgery procedures.
RECOMMENDATION: On July 29, 2011, Mizuho issued a Field Advisory Notice to Hospital Risk Management, Operating Room Directors, Operating Room Technicians, Physicians, Nurses, Anesthesiologists and any personnel involved in the use and/or set up of the OSI Modular Table Systems. The Field Advisory Notice provided 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.
Questions should be directed to Mizuho on their toll-free hotline at 1-800-777-4674, Monday through Friday from 9:00 am to 5 pm, Pacific Time.
Read the MedWatch safety alert, including a link to the Recall Notice, at:
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
