FDA Device recall Z-0122-2014
Aplio XG Diagnostic Ultrasound System SSA-790A 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 XG Diagnostic Ultrasound System SSA-790A 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-0122-2014 |
| 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 XG Diagnostic Ultrasound System SSA-790A 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: 99D0833447 99E0873714 99G0995029 99D0823343 99F0924404 99G09Y5216 99E…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 99C07828 |
|---|
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-0122-2014%22
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