FDA Medical Device Recalls (openFDA)
Hitachi Medical Systems America Inc: 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.
- Recall number
- Z-1341-2020
- Recalling firm
- Hitachi Medical Systems America Inc
- 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.
- Status
- Terminated
- Initiated
- 2020-01-31
- Posted
- not on file
- Terminated
- 2020-07-31
- Reason
- These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
- 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
- 18
- Distribution
- Domestic distribution to CA, FL, GA, MA, NV, OH, TX, and WV. Foreign distribution to Canada.
- Lot, serial or model codes
- Serial Number: G3007689, G3007688, G3007687, 206H2628, 206H2629, 206H2630, 206H2620, 206H2621, 206H2622, 206H2623, 206H26224, 206H2625, 206H2626, 206H2627, 205X3897, 205X3898, 205X3899, and 205X3900
- 510(k) numbers
- ["K134016","K142368","K162583"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 1528028
- Firm city
- Twinsburg
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28