Hitachi Arietta 850 Ultrasound System Recalled for Acoustic Output Error
Hitachi Medical Systems America Inc. is recalling Arietta 850 ultrasound systems with specific software versions due to an error that can cause acoustic output to exceed regulatory limits.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The rubric specifies that FDA Class II recalls with significant injury or property damage reports, or structural defects, are Severe. While no injuries are reported, the violation of regulatory limits for acoustic output on a medical device used for diagnostic imaging warrants a Severe rating under the Class II criteria for significant potential harm.
Plain-English summary
Hitachi Medical Systems America Inc. is recalling one unit of the Arietta 850 ultrasonic pulsed doppler imaging system. The recall affects systems running software versions 4.0.0, 4.0.1, or 4.0.2. The affected unit is identified by Asset Tag U8AR0479 and was distributed in Texas.
The recall is due to an error in the focus point and transducer aperture settings within the SWE function. When the affected software is used with the C252 probe, this error can result in Mechanical Index (MI) and Thermal Index (TI) acoustic output that is higher than regulatory limits.
The product is intended for use by trained personnel for diagnostic ultrasound evaluation. No specific instructions for consumers are provided in the source text, but the device is a professional medical device used by doctors and sonographers.
The recalled product
- Product
- 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.)
- Manufacturer
- Hitachi Medical Systems America Inc
- Affected units
- 1
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 (3)
- Asset Tag: U8AR0479 Arietta 850 software version 4.0.0.
- 4.0.1
- and 4.0.2
Distribution
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