Recall Z-1873-2011 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Toshiba American Medical Systems Inc
Toshiba Infinix-i, INFX-8000V The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body.
| Date | Apr 15, 2011 (initiated Dec 21, 2010) |
| Status | Terminated |
| Reason | Under some conditions during high doses procedures the cumulative air kerma display may reach its maximum capability and fail to display the accrued value. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | An Important: Electronic Product Radiation Warning notification was sent to all consignees. The letters described the reason for the recall and identified the affected product. The system software will be modified to allow the shift of the decimal to one position to the right allowing for a display of 99999.9 mGy. This will allow for the retention of the resolution until such time as the system exceeds the 9999.99 mGy range. A Toshiba Service person will contact customers when the software is available. Installed systems with the current version of software ( version 4.23) will begin to r |
| Quantity | 220 units Nationwide |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.