Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, Endoscopy clinical applications.
FDA Recall Z-1282-2021 · Posted None
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Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeIYN
Date Initiated2021-03-01
Date Terminated2021-11-04
Product Quantity1
Reason for Recall
Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transducer aperture settings in the SWE function. When the affected software with SWE function is used in conjunction with the C252 probe, this error can result in out of specification MI/TI acoustic output. The MI/TI acoustic output is higher than regulatory limits.
Firm Action
On 3/1/2021, Hitachi issued an Urgent Medical Device Correction notice to customers for the Arietta 850 system operating with software version 4.0.2 that utilizes SWE function with the C252 probe. The R&D department of Hitachi Ltd. (Manufacturer) has identified an error in the focus point and transducer aperture settings in the SWE function at the manufacturer facility. This error can result in out of specification MI/TI acoustic output. The MI/TI acoustic output is higher than regulatory limits.
Root Cause
Software design
Distribution Pattern
US Nationwide distribution in the state of TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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