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U.S. Department of Health and Human Services

Class 2 Device Recall TOSHIBA Kalare XRay System

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 Class 2 Recall
TOSHIBA Kalare XRay System
see related information
Date Posted July 10, 2013
Recall Status1 Open
Recall Number Z-1598-2013
Recall Event ID 65049
Premarket Notification
510(K) Number
K110785 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
Product TOSHIBA Kalare Diagnostic X-Ray System K110785
Code Information 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 2299 MAY 2010 31 99C0982250 2250 AUGUST 2008 32 99C1242381 2381 APRIL 2012 33 J1H08Z3448 3448 DECEMBER 2008 34 99C1252383 2383 MAY 2012 35 99C1022287 2287 FEBRUARY 2010 36 99C1072308 2308 JULY 2010 37 99C1042291 2291 APRIL2010 38 99C1042290 2290 APRIL2010 39 99C09X2258 2258 OCTOBER 2009 40 99B0892210 2210 SEPTEMBER 2008 41 99C1162355 2355 JUNE 2011 42 99C11X2364 2364 OCTOBER 2011 43 99C1162352 2352 JUNE 2011 44 99B08Y2216 2216 NOVEMBER 2008 45 99C11X2367 2367 OCTOBER 2011 46 99C12Y2396 2396 NOVEMBER 2012 47 99C1162354 2354 JUNE 2011 48 99C1012282 2282 JANUARY 2010 49 99C1042294 2294 APRIL 2010 50 99C0912227 2227 JANUARY 2009 51 99C12X2393 2393 OCTOBER 2012 52 99C0982251 2251 AUGUST2009 53 99C1182358 2358 AUGUST2011 54 99B08X2213 2213 OCTOBER 2008 55 99C1012279 2279 JANUARY 2010 NO. SERIAL# LAST FOUR MANUFACTURE DATE 56 99C1062305 2305 JUNE 2010 57 99D0962239 2239 JUNE 2009 58 99C0922230 2230 FEBRUARY 2009 59 99C0992255 2255 SEPTEMBER 2009 60 99C09Z2271 2271 DECEMBER 2009 61 99C1092317 2317 SEPTEMBER 2010 62 99C1212371 2371 JANUARY 2012 63 99C1052302 2302 MAY2010 64 99C1012284 2284 JANUARY 2010 65 99C1152349 2349 MAY2011 66 99C1082315 2315 AUGUST2010 67 99C10Y2327 2327 NOVEMBER 2010 68 99C1272387 2387 JULY 2012 69 99C0972243 2243 JULY 2009 70 99C1062304 2304 JUNE 2010 71 99C10X2324 2324 OCTOBER 2010 72 99C09X2263 2263 OCTOBER 2009 73 99C0992256 2256 SEPTEMBER 2009 74 J1109X3472 3472 OCTOBER 2009 75 99C09X2261 2261 OCTOBER 2009 76 99B08Y2219 2219 NOVEMBER 2008 77 99B08X2214 2214 OCTOBER 2008 78 99C09Y2268 2268 NOVEMBER 2009 79 99C1132346 2346 MARCH 2011 80 99C1012281 2281 OCTOBER 2010 81 99C1122341 2341 FEBRUARY 2011 82 99C1122342 2342 FEBRUARY 2011 83 99C12X2394 2394 OCTOBER 2012 84 99C12X2392 2392 OCTOBER 2012 85 99C0962241 2241 JUNE 2009 86 99C11X2365 2365 OCTOBER 2011 87 99C0952238 2238 MAY2009 88 99C0992257 2257 SEPTEMBER 2009 89 99C1152350 2350 MAY2011 90 J1H0973467 33467 JULY 2009 91 99C1012277 2277 JANUARY 2010 92 99C09Y2264 2264 NOVEMBER 2009 93 99C10Z2337 2337 DECEMBER 2010 94 J1H0953463 3463 MAY 2009 95 99B08Y2217 2217 NOVEMBER 2008 96 99C1222376 2376 FEBRUARY 2012 97 99C10X2325 2325 SEPTEMBER 2010 98 99C1032289 2289 MARCH 2010 99 J1109Y3476 3476 NOVEMBER 2009 100 99C1052300 2300 MAY 2010 101 99C1252384 2384 MAY 2012 102 99C1072312 2312 JULY 2010 203 99C1022286 2286 FEBRUARY 2010 104 99C0952237 2237 MAY 2009 105 99C0972245 2245 JULY 2009 106 99C10X2326 2326 OCTOBER 2010 107 99C1282388 2388 AUGUST 2012 108 99C1182360 2360 AUGUST 2011 109 99C08Z2221 2221 DECEMBER 2008 110 J111023482 3482 FBRUARY 2010 NO. SERIAL# . LASTFOUR .¿ MANUFACTURE DATE 111 99B08Y221S 221S NOVEMBER 2008 112 99C1092319 2319 SEPTEMBER 2010 113 99C1112340 2340 JANUARY 2011 114 99C093223S 223S MARCH 2009 115 99C0962240 2240 JUNE 2009 116 99B08X2211 2211 OCTOBER 2008 117 99C0922233 2233 FEBRUARY 2009 118 99C1092321 2321 SEPTEMBER 2010 119 99C0922229 2229 FEBRUARY 2009 120 99C11S23S1 23S1 MAY 2011 121 J1H08X3442 3442 OCTOBER 2008 122 99C1072310 2310 JULY 2010 123 99B08Y2218 2218 NOVEMBER 2008 124 99C11623S6 23S6 JUNE 2011 125 99C09Y2266 2266 NOVEMBER 2009 126 99C1142348 2348 APRIL 2011 127 J1110X3S04 3S04 OCTOBER 2010 128 Jli12S3S29 3S29 MAY2012 129 99C08Z2222 2222 DECEMBER 2008 130 99C0972242 2242 JULY 2009 131 99C091222S 222S SEPTEMBER 2012 132 99C09Y2267 2267 NOVEMBER 2009 133 99C0972247 2247 JULY 2009 134 99B08X2212 2212 OCTOBER 2008 135 99C1112339 2339 JANUARY 2011 136 99C1072313 2313 JULY 2010 137 99C09922S4 22S4 SEPTEMBER 2009 138 99C1092320 2320 SEPTEMBER 2010 139 99C0972244 2244 JULY 2009 140 99C10S2298 2298 MAY 2010 141 99C09Z2274 2274 DECEMBER 2009 142 99C104229S 229S APRIL2010 143 99C09Z2272 2272 DECEMBER 2009 144 99C11X2368 2368 OCTOBER 2011 145 99C1212373 2373 JANUARY 2012 146 99C10X2323 2323 OCTOBER 2010 147 99C1012283 2283 JANUARY 2010 148 99B0892209 2209 SEPTEMBER 2008 149 99C08Z2220 2220 DECEMBER 2008 150 99C08Z2223 2223 DECEMBER 2008 151 99C1142347 2347 APRIL 2011 152 99B0892207 2207 SEPTEMBER 2008 153 99C09Z227S 227S DECEMBER 2008
Recalling Firm/
Manufacturer
Toshiba American Medical Systems Inc
2441 Michelle Dr
P.O. Box 2068
Tustin, California 92780-7047
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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 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".
Quantity in Commerce 153 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAA and Original Applicant = TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN
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