Recall Z-0816-2018 ยท ITX Transducer, Ultrasonic, Diagnostic
Hitachi Medical Systems America Inc
Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.
| Date | Oct 20, 2017 |
| Status | Terminated |
| Reason | The ultrasound probe may not have adequate protection against electrical shock hazards. |
| Root cause | Mixed-up of materials/components |
| Action | Hitachi must recall the lot of UST-5550-R Transducers from S/N 1 to S/N 155. If you have a serial number in this range, please contact Hitachi Service at (800) 800-4925 to schedule the recall. Hitachi Sales will contact you regarding the options for a replacement transducer. |
| Quantity | 55 |
| Distribution | Distributed in 21 states: AR, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NY, OK, OR, PA, SC, TX, VA, WA, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152126 | UST-5550-R; UST-5536-R; L43K Hitachi Aloka Medical America, Inc., Aug 17, 2016 |