Operating Table Recall Issued After Reports of Patient Injuries

Reports that Mizuho operating tables could suddenly tilt and move patients in the middle of surgery has led a Class 1 recall, which is the FDA’s most serious category for a medical device recall. 

A Mizuho OSI Modular Table Systems recall was announced late last month by the manufacturer, and the FDA determined on Wednesday that the potential threat from the tables required a Class 1 Medical Device Recall designation, which suggests that the defect is likely to cause serious injury or death.

The operating table recall came following multiple reports of patient injuries that occurred when the tables unexpectedly moved or tilted during surgery.

The manufacturer has suggested that the problems appear to be linked to healthcare personnel removing the wrong T-pins used to support the table. However, it could be possible that the tables are tilting or moving without the wrong pins being removed, the FDA warns.

Mizuho first warned of possible problems and provided new safe use recommendations on July 29, but the FDA is concerned that the company is too focused on possible operator error and may not have identified all of the reasons for the table malfunctions.

The FDA did not report the number of injuries associated with the tilting tables, but it does not appear that any deaths have been linked to the operating tables.

The recall affects 14 models of Mizuho OSI Modular Table Systems, including:

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

The tables were manufactured and distributed from January 1992 to June 2011 and are used for patient positioning during a variety of surgeries.