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:
| Model | Product Name |
|---|---|
| 5803/5803I | Advanced Control Modular Base, 120VAC 60Hz or 230VAC 50/60Hz |
| 5890 | Retractable “I” Base - Manual tilt & lock functions |
| 5891 | Non-Retractable “I” Base - Manual tilt & lock functions |
| 5892 | Advanced Control Retractable “I” Base - electric powered tilt & lock |
| 5855 | Orthopedic Trauma Table Top |
| 5895 | Maximum Access Lateral Top |
| 5927 | Radiolucent Imaging Top with Tempur-Med |
| 5840-726 | Imaging Top w/ Tempur-med pad (part of Model 5827 System) |
| 5840-831 | Spinal Surgery Table Top (part of Jackson Spinal Surgery Top System) |
| 5943 | Jackson Spinal Table |
| 5843AP | Jackson Spinal Surgery Top w/Advanced Control Pad System 100/120VAC 50/60Hz |
| 5943API | Jackson Spinal Surgery Top w/Advanced Control Pad System 230VAC 50/60Hz |
| 5996/5996I | Advanced Control Pad System Variable Speed |
| 6977 | AXIS 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
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
