Recall Z-1598-2013 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Toshiba American Medical Systems Inc
TOSHIBA Kalare Diagnostic X-Ray System K110785
| Date | Jul 10, 2013 (initiated Apr 3, 2013) |
| Status | Terminated |
| Reason | Firm initiated recall because when radiographic conditions with the small focus are set and the radiography ready switch is held down, the large focus is also heated after a few seconds or more. This occurs when the Automatic Exposure Function (AEC) function is used. As a result, a radiographic tube current exceeding the set value flows and a brighter image than expected is acquired. |
| Root cause | Component design/selection |
| Action | Firm initiated recall by sending recall notification letters along with a customer reply form on April 3, 2013 via USPS return mail receipt. A follow-up letter (with customer reply form) was sent on April 11, 2013 to inform customers that they should continue to use the AEC function as usual. The updated letter along with the customer reply form dated April 11, 2013 was also sent via USPS return mail receipt. The letter titled, "URGENT: MEDICAL DEVICE CORRECTION", notified customers of the reason for recall, product description under recall, corrective action, instructions to customer under |
| Quantity | 153 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110785 | KALARE DIAGNOSTIC X-RAY TABLE SYSTEM Toshiba Medical Systems Coporation, Japan, May 27, 2011 |