FDA Device recall Z-1598-2013

TOSHIBA Kalare Diagnostic X-Ray System K110785

FDA Device
Class II
terminated
Published 2013-07-17

On 2013-07-17 the FDA classified a Class II recall of TOSHIBA Kalare Diagnostic X-Ray System K110785 by Toshiba American Medical Systems, citing 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 s….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1598-2013
Classification	Class II
Status	terminated
Initiated	2013-04-03
Published	2013-07-17
Last updated	2026-09-13 11:53 UTC
Company	Toshiba American Medical Systems
Distribution	US

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.

Identifiers

code_info	DREX-KL80 NO. SERIAL# LAST FOUR . MANUFACTURE DATE 1 99C1042292 2292 APRIL 2010 2 99C1162353 2353 JUNE 2011 3 99C… DREX-KL80 NO. SERIAL# LAST FOUR . MANUFACTURE DATE 1 99C1042292 2292 APRIL 2010 2 99C1162353 2353 JUNE 2011 3 99C1062307 2307 JUNE 2010 4 99C1072311 2311 JULY 2010 5 99C0972246 2246 JULY 2009 6 99C09Z2273 2273 DECEMBER 2009 7 99C1212372 2372 JANUARY 2012 8 99C0932234 2234 MARCH 2009 9 99C09X2262 2262 OCTOBER 2009 10 99C1182359 2359 AUGUST 2011 11 99C1022285 2285 FEBRUARY 2010 12 99C10Y2329 2329 NOVEMBER 2010 13 99C1092316 2316 SEPTEMBER 2010 14 99C1262385 2385 JUNE 2012 15 99C09Y2265 2265 NOVEMBER 2009 16 99C1122344 2344 FEBRUARY 2011 17 99C0982248 2248 AUGUST 2009 18 99C09Z2276 2276 DECEMBER 2009 19 99C1282389 2389 AUGUST 2012 20 99C1072309 2309 JULY 2010 21 99C0912228 2228 JANUARY 2009 22 99C1062303 2303 JUNE 2010 23 99C1212374 2374 JANUARY 2012 24 99C11Y2369 2369 NOVEMBER 2011 25 99C09X2260 2260 OCTOBER 2009 26 99C1042297 2297 APRIL2010 27 Jll1293530 3530 SEPTEMBER 2012 28 99C1012278 2278 JANUARY 2010 29 99C10Y2328 2328 NOVEMBER 2010 30 99C1052299 22

code_info

DREX-KL80 NO. SERIAL# LAST FOUR . MANUFACTURE DATE 1 99C1042292 2292 APRIL 2010 2 99C1162353 2353 JUNE 2011 3 99C…

DREX-KL80 NO. SERIAL# LAST FOUR . MANUFACTURE DATE 1 99C1042292 2292 APRIL 2010 2 99C1162353 2353 JUNE 2011 3 99C1062307 2307 JUNE 2010 4 99C1072311 2311 JULY 2010 5 99C0972246 2246 JULY 2009 6 99C09Z2273 2273 DECEMBER 2009 7 99C1212372 2372 JANUARY 2012 8 99C0932234 2234 MARCH 2009 9 99C09X2262 2262 OCTOBER 2009 10 99C1182359 2359 AUGUST 2011 11 99C1022285 2285 FEBRUARY 2010 12 99C10Y2329 2329 NOVEMBER 2010 13 99C1092316 2316 SEPTEMBER 2010 14 99C1262385 2385 JUNE 2012 15 99C09Y2265 2265 NOVEMBER 2009 16 99C1122344 2344 FEBRUARY 2011 17 99C0982248 2248 AUGUST 2009 18 99C09Z2276 2276 DECEMBER 2009 19 99C1282389 2389 AUGUST 2012 20 99C1072309 2309 JULY 2010 21 99C0912228 2228 JANUARY 2009 22 99C1062303 2303 JUNE 2010 23 99C1212374 2374 JANUARY 2012 24 99C11Y2369 2369 NOVEMBER 2011 25 99C09X2260 2260 OCTOBER 2009 26 99C1042297 2297 APRIL2010 27 Jll1293530 3530 SEPTEMBER 2012 28 99C1012278 2278 JANUARY 2010 29 99C10Y2328 2328 NOVEMBER 2010 30 99C1052299 22

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1598-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.