Device recall: UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic…

Class II FDA enforcement event 84838. Recall start date: 31 Jan 2020. Status in the FDA record: Terminated. Termination date: 31 Jul 2020.

Reason for recall, in the words of FDA

These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Hitachi Medical Systems America Inc started this device recall on 31 Jan 2020. The firm address in the FDA record is in Twinsburg, OH. FDA put the recall in Class II. FDA event 84838 has 1 product record. The first FDA enforcement report date is 26 Feb 2020. The record gives the status Terminated, with the termination date 31 Jul 2020.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Domestic distribution to CA, FL, GA, MA, NV, OH, TX, and WV. Foreign distribution to Canada.

Recalling firm

Hitachi Medical Systems America Inc, Twinsburg, OH.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 84838: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1341-2020	UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.	18	Class II	Terminated	26 Feb 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2020: 916
Share of these events in Class II: 93%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 15

Other events of the firm

Other FDA enforcement events of Hitachi Medical Systems America Inc
Initiated	Product (first record)	Type	Class	Records
1 Mar 2021	Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, et	Device	Class II	1
16 Oct 2019	Hitachi Scenaria Whole-body X-ray CT System	Device	Class II	1
29 Jun 2018	Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular	Device	Class II	1
18 Jun 2018	Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician	Device	Class II	1
20 Oct 2017	Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation d	Device	Class II	1
2 May 2017	Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultras	Device	Class II	1
6 Jan 2017	Hitachi Oasis MRI System - C-Spine Coil	Device	Class II	1
30 Jun 2015	Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087	Device	Class II	1
16 Apr 2015	Hitachi Oasis MRI System	Device	Class II	3
18 Aug 2014	Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the phy	Device	Class II	1

Hitachi Medical Systems America Inc: all 15 events

Official channels

FDA enforcement report Z-1341-2020The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 84838. https://recallregister.com/fda/ii/84838/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Domestic distribution to CA, FL, GA, MA, NV, OH, TX, and WV. Foreign distribution to Canada.
What quantity of product is in FDA event 84838?: The FDA record gives this quantity: 18
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.