TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volum
FDA device recall Z-2468-2012 · posted 2012-09-27 · Terminated
Recall details
- Recalling firm
- Toshiba American Medical Systems Inc
- Reason for recall
- 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.
- Action taken
- 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 Direction are HF. 2. When acquiring images for 4D perfusion analysis: " Perform scanning with the Scan Direction set to OUT when the Patient Insertion Direction and Scan Direction are HF. Perform scanning with the scan direction set to IN when the Patient Insertion Direction and Scan Direction are FF. Contact the firm at (800) 421-1968 for questions regarding this issue.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 3 units
- Distribution
- Nationwide distribution: USA including states of: MA, MD, and NV.
- Date initiated
- 2008-05-13
- Date posted
- 2012-09-27
- Date terminated
- 2012-09-27
- Location
- Tustin, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM (K072606) | Toshiba America Medical Systems, In.C | 2007-10-02 |