Z-1341-2020Class II

UST-2265-2 Probe, Part Number: UST-2265-2 -

Name: Z-1341-2020 UST-2265-2 Probe, Part Number: UST-2265-2 -
Creator: Hitachi Medical Systems America Inc
Published: 2020-01-31
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2020-01-31 / Terminated

FDA source

Hitachi Medical Systems America Inc began a recall of 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... on 2020-01-31. FDA classified it as Class II and gives the reason as "These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1341-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-31
Posted: 2020-02-20
Terminated: 2020-07-31
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: 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.
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
FDA root cause: Process change control
Action: On January 31, 2020, the firm initiated customer communications via Urgent Medical Device Recall letters. Customers were informed of the potential mis-wiring issue. Clinicians are advised to discontinue use of the probes to minimize adverse events. Hitachi Service will contact each affected site to schedule a service visit. Hitachi will test all affected probes and remove and replace any probes that do not pass the test. The correction is expected to begin February 2020.
Quantity in commerce: 18
Distribution: Domestic distribution to CA, FL, GA, MA, NV, OH, TX, and WV. Foreign distribution to Canada.
Product codes and lots: Serial Number: G3007689, G3007688, G3007687, 206H2628, 206H2629, 206H2630, 206H2620, 206H2621, 206H2622, 206H2623, 206H26224, 206H2625, 206H2626, 206H2627, 205X3897, 205X3898, 205X3899, and 205X3900

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1341-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1341-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-20

Product code ITX

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)