FDA Device recall Z-0121-2014
Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
- FDA Device
- Class II
- terminated
- Published 2013-11-06
On 2013-11-06 the FDA classified a Class II recall of Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging by Toshiba American Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0121-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-05 |
| Published | 2013-11-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | US |
Product
Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
Reason
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
Identifiers
| code_info | Lot Numbers not utilized. Serial Numbers: A1G1194387 A1E10Z3293 A1E10Z3294 99A09Y2120 99B09Z2178 99B09Z2179 A1F…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 A1C10828 |
|---|
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-0121-2014%22
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