Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
Medical device recall Z-0122-2014. 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
- 430 (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 XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
430 (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: 99D0833447 99E0873714 99G0995029 99D0823343 99F0924404 99G09Y5216 99E0863552 99E0863553 99G0964771 99C0792920 99F0893870 99B06Z2073 99C07X2964 99C0792918 99B06Z2063 99C0792919 99G0964712 99G0964713…
Every code shown here, 2,000 characters
Lot Numbers not utilized. Serial Numbers: 99D0833447 99E0873714 99G0995029 99D0823343 99F0924404 99G09Y5216 99E0863552 99E0863553 99G0964771 99C0792920 99F0893870 99B06Z2073 99C07X2964 99C0792918 99B06Z2063 99C0792919 99G0964712 99G0964713 99G0974899 99F0944563 99D0823349 99G0995131 99G0995132 99G0995133 99G0995134 99G09Y5224 99C0792914 99D0813229 99D0813230 99D0813231 99E0873711 99E0873716 99E0873717 99B06Z2072 99B0752508 99B0752509 99B0752510 99B0752511 99C0792915 99C0792937 99F0893967 99F08Y4079 99F08Y4085 99F08Y4086 99F0924389 99F0924395 99F0924405 99B06Z2107 99G1045683 99C07Y3068 99C07Y3069 99B0782760 99C07Y3047 99B0722268 99B0722269 99B0722270 99B0722271 99B0722272 99B0732349 99B0732350 99B0732351 99B0732352 99B0732353 99B0732354 99E0863691 99E0863692 99G0995139 99B0722208 99B0722250 99F0934520 99C0782863 99B06Z2061 99G0995071 99G09Y5260 99G09Y5261 99D0813225 99D0813226 99E0863586 99E0863587 99C0782860 99G0964777 99B0752531 99D07Z3138 99D0813224 99B0752532 99D07Z3139 99B06Z2088 99B0722251 99C07X2965 99F0914260 99F0914261 99F0914269 99G09Z5369 99G09Y5256 99F08Y4078 99D0833438 99G09Z5367 99F0893846 99E0873713 99B06Z2071 99C0782864 99C07Y3061 99D0833437 99G0974883 99G0974884 99F0893855 99F0893854 99B0782767 99B0782786 99F0914266 99G1015473 99G09Z5370 99G09Z5374 99G09Z5375 99G1015474 99B06Z2109 99B06Z2068 99B06Z2060 99C0792930 99D0823363 99D0833441 99D0823364 99D0823365 99D0833440 99G09Y5264 99B0722206 99B0722207 99B0722204 99B0752524 99B0752525 99F0914265 99F0914289 99E0873720 99G09Y5257 99F0893866 99F0893969 99D0823351 99B0732355 99B0742413 99B0742414 99G0995135 99D0823342 99E0863572 99D0833450 99E0863549 99E0863550 99E0873712 99E0863570 99E0863571 99B06Z2055 99D0833451 99B0742415 99B0742416 99B0742417 99G09Y5223 99F0914263 99B0722203 99B0782788 99C0782866 99B06Z2062 99F0934528 99B0782766 99B0722201 99F0893961 99F0934532 99G09Z5379 99G1015468 99F0924394 99G1015472 99G09Y5262 99G09Y5263 99B0722252 99G0974886 99F0893868 99F0893869 99G0964772 99F0944536 99F0893851…
FDA’s list runs to 4,782 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 4,782 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.