TOSHIBA Kalare Diagnostic X-Ray System K110785

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.

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 1. A new circuit board will be installed in each involved unit by a Toshiba service representative, without any charge to the user. 2. In the meantime while waiting for service, the user is to continue using the device with the AEC function. If the AEC function is not available, the user should push the radiography READY and EXPOSURE switches at the same time. "Note to Customer", and contact information "(800) 421-1968 or your local Toshiba Representative at (800) 521-1968".