Diagnostic Ultrasound System — Class II medical device recall Z-2315-2018
Terminated recall by Toshiba American Medical Systems Inc, reported 2018-07-04, distributed nationwide. The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power out
| Recall number | Z-2315-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Toshiba American Medical Systems Inc, Tustin, CA, United States |
| Recall initiated | 2018-01-04 |
| Classified | 2018-06-28 |
| Reported by FDA | 2018-07-04 |
| Terminated | 2023-10-10 |
| Distributed | Nationwide (US) |
| Quantity | 162 units |
| Reason classes | device malfunction |
| Serial numbers | HAB16Z2001, HAB16Z2002, HAB16Z2003, HAB16Z2004, HAB16Z2005, HAB1712006, HAB1712007, HAB1712008, HAB1712009, HAB1712010, HAB1722011, HAB1722012, HAB1732006, HAB1732007, HAB1732008, HAB1732009, HAB1732010, HAB1732013, HAB1732014, HAB1732015, HAB1732016, HAB1732017, HAB1732018, HAB1732019, HAB1732020 and 186 more |
| Model numbers | TUS-AI700, TUS-AI800, TUS-AI900 |
Product
Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.
Reason for recall
The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2315-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.