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.
FDA Recall Z-0816-2018 · Posted None
Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeITX
Date Initiated2017-10-20
Date Terminated2020-04-16
Product Quantity55
Reason for Recall
The ultrasound probe may not have adequate protection against electrical shock hazards.
Firm 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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.