Mizuho OSI Modular Table Systems are intended to assist in the treatment of those receiving surgery to correct orthopedic trauma. More specifically, the system helps to place patients in the optimal position to receive proper treatment for significant spinal injuries. Unfortunately, components of the system may demonstrate a propensity for failure and subsequent injury. Accordingly, the U.S. Food and Drug Administration (FDA) has notified healthcare professionals of a Class I Mizuho OSI Modular Table System recall.
If you or a loved one has been injured by a Mizuho OSI Modular Table System, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Mizuho OSI Modular Table System Recall Lawsuit Overview
As a prominent leader in the medical device industry, Mizuho OSI has been designing and manufacturing innovative, high quality equipment for the medical community for over 25 years. The company was founded in 1978 as Orthopedics Systems, Inc., and is now a subsidiary of the Mizuho Ikakogyo Co., Ltd., in Tokyo, Japan who acquired Mizuho OSI in 2002. Mizuho is the leading surgical table manufacturer in Japan and Asia with significant share of the U.S. general surgery table market as well. Mizuho OSI’s operation strategy focuses on operating room equipment that is intended to improve surgical procedures through advanced patient positioning. The company offers a wide number of highly specialized surgical tables for spinal, joint replacement and orthopedic trauma surgery as well as tables for comprehensive imaging procedures required by today’s minimally invasive procedures.
Unfortunately, the FDA acknowledged a number of reported injuries that were associated with the use of these table systems. The following is an FDA Safety Alert that identifies patient injuries that have resulted from the use of Mizuho products:
The 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.
Models Included in Recall
The following is a list of the products that have been associated with injuries and are included in the recent Mizuho OSI Modular Table System recall:
- Advanced Control Modular Base 120VAC 60Hz or 230VAC 50/60Hz/model 5803/5803I.
- Retractable “I” Base with manual tilt and lock functions/model 5890.
- Non-Retractable “I” Base with manual tilt and lock functions/model 5891.
- Advanced Control Retractable “I” Base—electric-powered tilt and lock/model 5892.
- Orthopedic Trauma Table Top/model 5855.
- Maximum Access Lateral Top/model 5895.
- Radiolucent Imaging Top with Tempur-Med/model 5927.
- Imaging Top with Tempur-Med Pad (part of the Model 5827 system)/model 5840-726.
- Spinal Surgery Table Top (part of Jackson Spinal Surgery Top system)/model 5840-831
- Jackson Spinal Table/model 5943.
- Jackson Spinal Surgery Top with the Advanced Control Pad System 100/120VAC50/60Hz/model 5843AP.
- Jackson Spinal Surgery Top with the Advanced Control Pad System 230VAC50/60Hz/model 5943API.
- Advanced Control Pad System Variable Speed/model 5996/5996I.
- AXIS Jackson System with the Advanced Control Pad system 100/230VAC50/60Hz/model 6977
Hospital Risk Notice
On July 29, 2011, Mizuho, in response to previous model complications, 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. According to the notice, Mizuho warned the healthcare community of potential injuries that may be a result of using their table systems. The Field Advisory Notice provided warnings and recommendations for safe use of their products. The notice focused on the issue of T-pins used to stabilize the system. Reports suggest that the improper removal of these components may result in a patient falling to the floor. If such an event was to happen during surgery, the ramifications could potentially result in catastrophic injuries or even death.
Do I Have a Mizuho OSI Modular Table System Recall Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Mizuho OSI Midular Table System lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by a Mizuho OSI Modular Table System, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.