Recall Z-2167-2014 ยท JOP Transducer, Ultrasonic
Biosound Esaote, Inc.
Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
| Date | Aug 8, 2014 (initiated Jun 26, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | On 06/26/2014, Esaote North America sent an advisory letter via FEDEX (with signature required) to each customer or consignee affected by this voluntary recall. The packet contained the advisory letter, including actions to be taken by the user, information about a pending software upgrade, and a business reply card to confirm they received the letter and have the equipment noted on the advisory letter. Customers with questions were instructed to call 800-428-7378. For questions regarding this recall call 1-317-813-6005 |
| Quantity | 1,301 units |
| Distribution | Nationwide-Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI & WV. International**Product was also shipped to consignees i |
| FDA record | Open on fda.gov |