FDA Recall
Terminated
Toshiba DUA-450F Kalare Radiographic Tilting Table.
Recall: Z-1675-2011
·
Initiated July 15, 2010
Recall
- Recall Number
- Z-1675-2011
- Event Number
- 56415
- Firm
- Toshiba American Medical Systems Inc
- FEI Number
- 2020563
- Product Code
- IXR
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- July 15, 2010
- Posted
- March 16, 2011
- Terminated
- April 20, 2012
- Address
- 2441 Michelle Dr P.O. Box 2068, Tustin, CA, 92781-2068
Description
Toshiba DUA-450F Kalare Radiographic Tilting Table.
Reason
Top table lateral movement on their DUA-450F Kalare Table cannot be performed, or the table top lateral movement is performed at an extremely low speed. As a result, positioning of the patient cannot be performed by tabletop movement.
Action
Toshiba America Medical Systems (TAMS) issued Urgent Medical Device Correction notification dated July 8, 2010, to consignees via USPS return receipt mail. The letter contains a return reply form that is to be faxed to TAMS as proof of notification.
Distribution
US Nationwide
Quantity
238 systems