Recall Z-2339-2010 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
Toshiba Aquilion ONE CT SystemTSX-301 A/2D
| Date | Sep 1, 2010 (initiated Feb 3, 2009) |
| Status | Terminated |
| Reason | ECG Gated Dynamic Volume Prospective scan may stop if preset eXam Plan is confirmed and CTA On is changed to CTA OFF, due to exposure control PWB. |
| Root cause | Software design |
| Action | Toshiba America Medical System Inc (TAMS) sent an Urgent: Medical Device Correction dated January 14, 2009 to their consignees. The letter described the issue and provided instructions to test the device to determine if it is an affected device. If the device is affected, contact the Toshiba service representative at 800 521-1968. Consignees were requested to complete and fax a response form to Toshiba. |
| Quantity | 16 |
| Distribution | Nationwide Distribution: including the states of AL, CA, FL, GA, KY, MA, MD, MT, NV, NY, OH, PA, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072606 | AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM Toshiba America Medical Systems, In.C, Oct 2, 2007 |