The U.S. Food & Drug Administration (FDA) has issued a press release notifying healthcare professionals that Mizuho OSI Modular Table Systems are being recalled nationwide because of patient injury related accidents. According to the FDA’s statement, a potentially defective design and improper usage of the Mizuho Table Systems may result in unanticipated movement and patient falls. This is a Class I Recall, which means that the product in question could cause serious injuries or even death.
Free Mizuho OSI Modular Table System Recall Lawsuit Evaluation: If you or a loved one has been injured by a Mizuho OSI Modular Table System included in this recall, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the Mizuho OSI Modular Table System and we can help.
What’s the problem?
November 9, 2011 - The recall [1] of the Mizuho OSI Modular Table System was initiated because it was found that the incorrect removal of the T-pins that support the bottom base of the device may result in patients unexpectedly falling to the floor. Additionally, it has been reported that unanticipated movement or tilting of the table may result in patient falls during surgery. Patient falls or unanticipated movement during a surgical procedure can result in catastrophic injuries or even death.
The Mizuho OSI Modular Table Systems included in this recall are designed for patient positioning during a variety of orthopedic trauma, thoracic, and spinal surgery procedures. The products in question were manufactured and distributed between January 1992 and June 2011. The following models are involved in this Class I 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
In July, the manufacturer circulated a Field Advisory Notice to all parties potentially involved in the use and/or set up of the OSI Modular Table Systems. The notice provided warnings and recommendations for the safe use of the devices, including performing a verification count of all the T-pins to confirm the stability of the table top.
The FDA has stated that it is concerned that Mizuho has still not identified all the contributing factors involved in the adverse event reports surrounding its products. The administration also stated that healthcare professionals and consumers may report problems with Mizuho OSI Modular Table Systems to MedWatch: The FDA Safety Information and Adverse Event Reporting System [2].
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Free Mizuho OSI Modular Table System Recall Lawsuit Evaluation: If you or a loved one has been injured by a Mizuho OSI Modular Table System included in this recall, you should contact our law firm immediately. You may be entitled to compensation by filing a Mizuho OSI Modular Table System recall suit and we can help.
