Hitachi Medical Systems Recalls 18 Ultrasound Probes Due to Mis-Wiring
Hitachi Medical Systems America Inc is recalling 18 UST-2265-2 ultrasound probes due to potential mis-wiring that may cause decreased sensitivity and lower peak velocity readings.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could lead to inaccurate diagnostic readings (lower peak velocity), which poses a risk of harm through misdiagnosis, but no injuries or illnesses have been reported.
Plain-English summary
Hitachi Medical Systems America Inc is recalling 18 units of the UST-2265-2 ultrasound probe. The product is intended 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 applications.
The recall is being issued because the probes may have mis-wiring in the inner cables. This defect can cause decreased sensitivity, resulting in lower peak velocity readings. The affected units were distributed domestically to California, Florida, Georgia, Massachusetts, Nevada, Ohio, Texas, and West Virginia, as well as to Canada.
Healthcare facilities and users should stop using the affected probes and contact Hitachi Medical Systems America Inc for instructions on how to return or replace the devices. The specific serial numbers for the recalled units are listed in the official recall documentation.
The recalled product
- 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.
- Manufacturer
- Hitachi Medical Systems America Inc
- Affected units
- 18
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- Serial Number: G3007689
- G3007688
- G3007687
- 206H2628
- 206H2629
- 206H2630
- 206H2620
- 206H2621
- 206H2622
- 206H2623
- 206H26224
- 206H2625
- 206H2626
- 206H2627
- 205X3897
- 205X3898
- 205X3899
- and 205X3900
Distribution
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