Esaote PA230E Transducer A portable and cart base ultrasound system… — Class II medical device recall Z-2167-2014
Terminated recall by Biosound Esaote, Inc., reported 2014-08-20, distributed nationwide. Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode foc
| Recall number | Z-2167-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosound Esaote, Inc., Indianapolis, IN, United States |
| Recall initiated | 2014-06-26 |
| Classified | 2014-08-08 |
| Reported by FDA | 2014-08-20 |
| Terminated | 2015-07-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,301 units |
| Serial numbers | 07011, 10005, 10007, 10010, 10011, 10012, 10013, 10015, 10017, 10021, 10042, 10068, 10070, 10079, 10085, 10086, 10087, 10088, 10089, 10092, 10101, 10102, 10117, 10139, 10149 and 475 more |
| Model numbers | 9600165000, 97154411675 |
Product
Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
Reason for recall
Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature to exceed the maximum allowable limit.
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-2167-2014. 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.