Toshiba DUA-450F Kalare Radiographic Tilting Table.
FDA Recall Z-1675-2011 · Posted 2011-03-16
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Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeIXR
Date Initiated2010-07-15
Date Terminated2012-04-20
Product Quantity238 systems
Reason for Recall
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
US Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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