Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
Medical device recall Z-0121-2014. Published in FDA’s Enforcement Report on Nov 6, 2013.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 6, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 427 units (1352 total) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
427 units (1352 total), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Numbers not utilized. Serial Numbers: A1G1194387 A1E10Z3293 A1E10Z3294 99A09Y2120 99B09Z2178 99B09Z2179 A1F1143915 A1G1194385 A1G1194394 A1G1194395 A1G1194396 A1E10Z3339 A1E10Z3340 A1E10Z3341 A1G11Z4565 99B09Z2174 A1G1174188 A1G1194355…
Every code shown here, 2,000 characters
Lot Numbers not utilized. Serial Numbers: A1G1194387 A1E10Z3293 A1E10Z3294 99A09Y2120 99B09Z2178 99B09Z2179 A1F1143915 A1G1194385 A1G1194394 A1G1194395 A1G1194396 A1E10Z3339 A1E10Z3340 A1E10Z3341 A1G11Z4565 99B09Z2174 A1G1174188 A1G1194355 A1G1194356 A1G1184257 A1G1184258 A1G1194392 A1G1194406 99B1022343 A1F1113439 A1F1133733 A1F1133846 A1C1072756 A1C1072763 A1C1082867 99A09X2090 99A09X2092 A1C1093010 A1G1214637 A1G11Z4566 A1E10Z3295 A1E10Z3308 A1E10Z3312 A1G1194397 A1E10Z3311 A1F1123626 A1F1123633 A1C1082816 A1C1082830 A1C1082837 A1C1082838 A1C1082842 A1C1082843 A1C1082847 A1G1194373 A1F1123624 A1G1194393 A1F1133840 99B1032438 A1F1113440 A1F1113443 A1F1113444 A1F1133863 A1F1123693 A1F1133760 A1F1133772 A1F1133773 A1C1092961 A1C1092970 A1B1062657 A1E10Z3296 A1G11Z4575 A1F1133740 A1F1133780 A1C1093018 A1G1194384 A1F1133776 A1G1184302 A1G1184303 A1G1194364 A1G1194371 A1G1194372 A1C1082874 A1B1062687 A1C1082868 A1C1082873 A1C1082851 A1C1082862 A1C1082856 A1C1082884 A1G1214636 A1C1082861 A1C1082879 A1C1082880 A1C1082885 A1G1184256 A1G1194401 A1E10Z3359 A1E10Z3360 A1E10Z3361 A1E10Z3369 A1E10Z3370 A1E10Z3371 A1F1123625 A1F1113455 A1A1042483 A1B1052583 A1C1072774 A1C1072782 99B1022344 99B1022347 A1A1042474 A1A1042477 A1A1042480 A1A1042496 99B1032444 A1C1092929 99A09X2087 99A09X2091 99A09Y2114 A1G11Z4568 A1F1133737 A1G1194383 99B1032416 99B09Z2173 99B09Z2182 A1G1184276 A1E10Z3306 A1E10Z3307 A1F1123614 A1B1062646 A1B1062651 A1G1194379 A1E10Z3326 99B09Z2180 99B09Z2181 A1G11Z4567 A1F1123665 99B09Z2171 A1B1062664 A1B1062665 99B1032437 A1F1143918 A1E10Z3356 A1G1194398 99A09Y2116 99B1012242 A1F1123679 A1G1194377 A1C1092920 99B1012227 A1F1133875 99A09X2094 A1A1042491 A1A1042501 A1B1052571 A1F1113466 99B1022345 99B1022346 A1B1062656 A1B1062691 A1B1062696 A1F1133862 A1A1042513 A1B1052569 A1G1184296 99B1012243 A1F1143887 A1B1062634 A1F1133763 A1F1123692 A1E10Z3357 99B1022351 A1G1184289 A1G1184295 A1G1194403 A1F1133762 99B1032447 99A09X2095 99A09Y2113 A1F1143927 A1F1113442 A1F1133764…
FDA’s list runs to 4,738 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide Distribution including and US Territory Puerto Rico
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 5, 2013.
- FDA classified it on Oct 30, 2013.
- FDA’s Enforcement Report published it on Nov 6, 2013.
- FDA terminated it on Jun 28, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Toshiba American Medical Systems Inc, of Tustin, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,738 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.