Ultrasonic pulsed doppler imaging system - Product recall: Software Issue
Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic…
Why was Ultrasonic pulsed doppler imaging system - Product recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Asset Tag: U8AR0479 Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2
- Product
- Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic…
- Recalling firm
- Hitachi Medical Systems America Inc
- Quantity
- 1
- Distribution
- US Nationwide distribution in the state of TX.
- Recall date
- March 31, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)