Sonesta 6210 Fluoroscopy Procedure Table; a motorized procedure table with adjustments (via a remote control) for height

FDA device recall Z-0119-2009 · posted 2008-10-20 · Terminated

Recall details

Recalling firm

Stille AB

Reason for recall

The table contains a battery backup, not mentioned in the User Manual, which automatically will provide power to the electrical actuators/motions in case of a power loss from the main power supply. However, if a short circuit occurs, it can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device from the main power supply, as the battery automatically w

Action taken

Stille sent Field Safety Notices dated 8/27/08 to the direct accounts, informing them that the table contains a battery backup, not mentioned in the User Manual, which automatically will provide power to the electrical actuators/motions in case of a power loss from the main power supply. However, if a short circuit occurs, it can result in an uncontrolled movement of the table which cannot be stopped by disconnecting the device from the main power supply, as the battery automatically will supply continuous power to the control box. The accounts were requested to complete and return the enclosed acknowledgement card to Stille by fax or e-mail as soon as possible and no later than 9/26/08. The accounts were advised to not further use the table in conjunction with a C-arm or any other heavy object until a service technician can permanently remove the battery from the control box according to the enclosed Service Manual Amendment No. 1. Stille will make a permanent correction to the table once it has been validated and approved. Contact Stille Surgical Inc. at 1-800-655-1614 for assistance.

Root cause

Component design/selection

Status

Terminated

Product code

IXR

Quantity affected

114 units

Distribution

Nationwide and Canada

Date initiated

2008-08-27

Date posted

2008-10-20

Date terminated

2010-12-10

Location

Solna, Sweden