Recall Z-0816-2018— Hitachi Medical Systems America Inc

Name: FDA recall Z-0816-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-20

Class II · Terminated

Class II FDA medical device recall by Hitachi Medical Systems America Inc, initiated 2017-10-20, terminated 2020-04-16. It names one FDA 510(k) clearance: K152126. Product: 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.. Reason: The ultrasound probe may not have adequate protection against electrical shock hazards..

Recalling firm: Hitachi Medical Systems America Inc
Classification: Class II
Status: Terminated
Initiated: 2017-10-20
Terminated: 2020-04-16
Firm location: Twinsburg, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K152126 — UST-5550-R; UST-5536-R; L43KHitachi Aloka Medical America, Inc.·cleared 2016-08-17

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

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.

Reason for recall

The ultrasound probe may not have adequate protection against electrical shock hazards.

Data sourced from openFDA. This site is unofficial and independent of the FDA.