Recall – Ultrasonic pulsed doppler imaging system focus point error

Company: Hitachi Medical Systems America Inc
Date of Enforcement Report: 3/31/2021
Class II

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.

Recall Number: Z-1282-2021

REASON

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.

RECALLING FIRM/MANUFACTURER

Hitachi Medical Systems America Inc on 3/1/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

1

DISTRIBUTION

U.S. Nationwide

Upcoming SoftwareCPR Training Courses:

Public Course – Oct 18-21, 2022 – Being Agile & Yet Compliant (virtual)

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Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

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  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Early Bird Discount Registration through September 30, 2022.  Reserve your spot!

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Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.