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U.S. Department of Health and Human Services

Class 2 Device Recall ALOKA ARIETTA 850SE

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  Class 2 Device Recall ALOKA ARIETTA 850SE see related information
Date Initiated by Firm March 01, 2021
Create Date March 19, 2021
Recall Status1 Terminated 3 on November 04, 2021
Recall Number Z-1282-2021
Recall Event ID 87493
510(K)Number K183456  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
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.), 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.
Code Information Asset Tag: U8AR0479  Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2
Recalling Firm/
Manufacturer		 Hitachi Medical Systems America Inc
1959 Summit Commerce Park
Twinsburg OH 44087-2371
For Additional Information Contact Aaron J. Pierce
330-425-1313 Ext. 3720
Manufacturer 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.
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 1
Distribution US Nationwide distribution in the state of TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = Hitachi Healthcare Americas
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