Recall Z-1598-2013— Toshiba American Medical Systems Inc

Name: FDA recall Z-1598-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-03

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2013-04-03, terminated 2016-02-05. It names one FDA 510(k) clearance: K110785. Product: TOSHIBA Kalare Diagnostic X-Ray System K110785. 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..

Recalling firm: Toshiba American Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2013-04-03
Terminated: 2016-02-05
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K110785 — KALARE DIAGNOSTIC X-RAY TABLE SYSTEMToshiba Medical Systems Coporation, Japan·cleared 2011-05-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TOSHIBA Kalare Diagnostic X-Ray System K110785

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.