Toshiba DUA-450F Kalare Radiographic Tilting Table.
FDA device recall Z-1675-2011 · posted 2011-03-16 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- IXR
- Quantity affected
- 238 systems
- Distribution
- US Nationwide
- Date initiated
- 2010-07-15
- Date posted
- 2011-03-16
- Date terminated
- 2012-04-20
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST (K922364) | Toshiba America Medical Systems, In.C | 1992-09-04 |