Recall Z-2468-2012 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of the anatomy. Additionally the system, when used by a trained professional, is capa
| Date | Sep 27, 2012 (initiated May 13, 2008) |
| Status | Terminated |
| Reason | The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function. |
| Root cause | Software design |
| Action | Toshiba American Medical Systems, Inc. sent an "URGENT: MEDICAL DEVICE CORRECTION" letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. customers: The firm advised customers to take the following temporary measures to avoid issues until a corrective action has been taken: I. In SureStart: " Perform scanning with Observation Direction set to VFF when the Patient Insertion Direction and Observation direction are FF. " Perform scanning with the Observation direction set to VFH when the Patient Insertion Direction and Observation |
| Quantity | 3 units |
| Distribution | Nationwide distribution: USA including states of: MA, MD, and NV. |
| 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 |