Recall Z-2167-2014— Biosound Esaote, Inc.
Class II · Terminated
Class II FDA medical device recall by Biosound Esaote, Inc., initiated 2014-06-26, terminated 2015-07-17. It names 3 FDA 510(k) clearances: K110688, K050326, K040596. Product: Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging. Reason: 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..
- Recalling firm
- Biosound Esaote, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-26
- Terminated
- 2015-07-17
- Firm location
- Indianapolis, IN, United States
510(k) clearances named in this recall
3 on FDA's record- K110688 — MYLABGOLD
- K050326 — 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350
- K040596 — ULTRASOUND IMAGING SYSTEM, MODEL 7300
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.