Recall record at a glance
| Official record | Z-0192-2022 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | FujiFilm Healthcare Americas Corporation |
| Report date | Nov 10, 2021 |
| Recall initiation date | Oct 14, 2021 |
| Quantity | 48 US |
| Location | Twinsburg, OH, United States |
Official product description
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Why the product was recalled
When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow combined with Left Ventricular Outflow Tract Flow (LVOT Flow) after performing an echocardiogram. The incorrect value is displayed. In addition, the error appears in the instruction manual
Distribution information
US Nationwide distribution.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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