Recall Z-2282-2012 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
| Date | Aug 28, 2012 (initiated Jul 13, 2009) |
| Status | Terminated |
| Reason | 1. It has been found that in raw data processing for Go&Return helical scanning, when the raw data acquired in the first scan (Go) and that acquired in the second scan (Return) are selected and reconstructed at one time, incorrect couch positions and scan times are displayed on the reconstructed images for the data acquired by Return scanning, while all related information is displayed on the reco |
| Root cause | Software design |
| Action | The firm, Toshiba America Medical Systems, Inc., sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated July 30, 2009 to its Consignees/customers. The letter described the product, problem and actions to be taken. The letter informed them of the above mentioned reason for recall and telling them that a corrective measure will be installed to prevent the occurrence of the above problems. They were told that their Toshiba service representative will contact them to install the measures. Furthermore Toshiba instructed them to adopt the following temporary measures to avoid these phenomena unt |
| Quantity | 24 Systems |
| Distribution | Nationwide distribution: USA including states of: AL, AR, CA, CO, FL, GA, KY, MA, MD, MT, ND, NJ, 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 |