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Terminated

Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.

FDA Recall Z-2090-2017 · Posted None

Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeIYN
Date Initiated2017-05-02
Date Terminated2018-11-19
Product Quantity77

Reason for Recall

The strength of the arm mounting mechanism was insufficient and had to be redesigned.

Firm Action

An Urgent: Device Correction Notice was sent via overnight carrier on 5/5/17. The Notice identified the affected product and problem. The firm will replace the Monitor Arm to correct the issue at no cost to the customer. If the problem occurs, customers are to call 800-800-4925 for immediate service. Hitachi Service will update the hardware at each site. Customers can contact [email protected] with questions, comments, or requests regarding the Notice.

Root Cause

Device Design

Distribution Pattern

Distributed to the states of: AZ, CA, FL, HI, IL MA, MD, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, and TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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