Home / Recalls / Medical Devices
Toshiba American Medical Systems Inc recalls TOSHIBA Kalare Diagnostic X-Ray System K110785
Recalled July 17, 2013 · FDA recall Z-1598-2013 · Toshiba American Medical Systems
Hazard
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. · FDA Class II
Units
153 units
Sold at
US Nationwide Distribution
Description
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.
Product
TOSHIBA Kalare Diagnostic X-Ray System K110785
Manufacturer(s)
Toshiba American Medical Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →