Tuesday, November 15, 2011

Mizuho OSI Modular Table Systems Recall

From the FDA site: 
Product: OSI Modular Table Systems (including Modular Bases, Jackson Spinal, Imaging, Lateral, & Orthopedic Tops)
Manufacturing From: January 1992 - June 2011
Distribution From: January 1992 - June 2011
The affected models and lot numbers can be found below:
ModelProduct Name
5803/5803IAdvanced Control Modular Base, 120VAC 60Hz or 230VAC 50/60Hz
5890Retractable “I” Base - Manual tilt & lock functions
5891Non-Retractable “I” Base - Manual tilt & lock functions
5892Advanced Control Retractable “I” Base - electric powered tilt & lock
5855Orthopedic Trauma Table Top
5895Maximum Access Lateral Top
5927Radiolucent Imaging Top with Tempur-Med
5840-726Imaging Top w/ Tempur-med pad (part of Model 5827 System)
5840-831Spinal Surgery Table Top (part of Jackson Spinal Surgery Top System)
5943Jackson Spinal Table
5843APJackson Spinal Surgery Top w/Advanced Control Pad System 100/120VAC 50/60Hz
5943APIJackson Spinal Surgery Top w/Advanced Control Pad System 230VAC 50/60Hz
5996/5996IAdvanced Control Pad System Variable Speed
6977AXIS Jackson System with Advanced Control Pad System 100/230 VAC 50/60Hz
Use: For patient positioning during a diverse set of orthopedic trauma, thoracic, and spinal surgery procedures.
Recalling Firm: 
Mizuho Orthopedic Systems Inc
30031 Ahem Avenue
Union City, CA 94587
Reason for Recall: There are reports of injury related incidents while using Mizuho OSI Modular Table Systems. The incorrect removal of the T-pins that support the bottom base, instead of the T-pins that support the top, may result in the lower table top and patient 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. Both of the above may result in serious injury or death

Enhanced by Zemanta