Recall Z-2090-2017— Hitachi Medical Systems America Inc
Class II · Terminated
Class II FDA medical device recall by Hitachi Medical Systems America Inc, initiated 2017-05-02, terminated 2018-11-19. It names one FDA 510(k) clearance: K134016. Product: Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.. Reason: The strength of the arm mounting mechanism was insufficient and had to be redesigned..
- Recalling firm
- Hitachi Medical Systems America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-02
- Terminated
- 2018-11-19
- Firm location
- Twinsburg, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.
Reason for recall
The strength of the arm mounting mechanism was insufficient and had to be redesigned.
Data sourced from openFDA. This site is unofficial and independent of the FDA.