Z-0816-2018Class II

Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system...

Name: Z-0816-2018 Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system...
Creator: Hitachi Medical Systems America Inc
Published: 2017-10-20
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2017-10-20 / Terminated

FDA source

Hitachi Medical Systems America Inc began a recall of Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic... on 2017-10-20. FDA classified it as Class II and gives the reason as "The ultrasound probe may not have adequate protection against electrical shock hazards". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0816-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-20
Posted: 2018-03-01
Terminated: 2020-04-16
Recalling firm: FUJIFILM Healthcare Americas Corporation
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.
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: The ultrasound probe may not have adequate protection against electrical shock hazards.
FDA 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 in commerce: 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.
Product codes and lots: 17 21 32 37 38 39 41 43 45 46 48 57 58 59 61 63 64 69 73 77 78 81 82 86 87 92 96 97 99 107 108 109 114 115 116 118 120 121 122 126 129 130 132 135 139 140 141 143 144 147 148 151 155

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0816-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0816-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01

Product code ITX

K152126Class IIUst-5550-R; Ust-5536-R; L43kHitachi Aloka Medical America, Inc. / cleared 2016-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)