Recall Z-2090-2017 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Hitachi Medical Systems America Inc
Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.
| Date | May 2, 2017 |
| Status | Terminated |
| Reason | The strength of the arm mounting mechanism was insufficient and had to be redesigned. |
| Root cause | Device Design |
| 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 recalls@hitachihealthcare.com with questions, comments, or requests regarding the Notice. |
| Quantity | 77 |
| Distribution | Distributed to the states of: AZ, CA, FL, HI, IL MA, MD, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K134016 | ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical, Mar 28, 2014 |