Recall Z-3221-2011 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
TSX-101: Aquilion 32/64; System, X-Ray, Tomography, Computed.
| Date | Sep 16, 2011 (initiated Dec 8, 2010) |
| Status | Terminated |
| Reason | There is the potential that the current may not be controlled correctly in examinations using the ECG modulation function, which adjusts the x-ray output in synchronization with the ECG waveform. |
| Root cause | Software design |
| Action | Toshiba America Medical Systems (TAMS) issued an Urgent: Medical Device Correction notification to consignees via USPS return receipt mail. The letter identified the affected product, the problem, and corrective action. The firm plans to install revised firmware to prevent the occurrence of the problem. A Toshiba Service Representative will contact customers to schedule an appointment for installation. The firm asked customers to stop using the Power Reduction option during ECG modulated scanning until the new firmware has been installed. Customers are to share the information in the lett |
| Quantity | 528 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080211 | MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM Toshiba America Medical Systems, In.C, Mar 14, 2008 |