Twinsburg, OH, United States
Hitachi Medical Systems America Inc recalls
6 recalls recorded since 2018, most recently on 1 March 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)0
Terminated or completed6
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 1 March 2021
- Terminated
- 4 November 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.
- Distribution
- US Nationwide distribution in the state of TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1282-2021
- 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.), Intraoper
Terminated Class II Medical devices
- Recall started
- 31 January 2020
- Terminated
- 31 July 2020
- Reason
- These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.
- Distribution
- Domestic distribution to CA, FL, GA, MA, NV, OH, TX, and WV. Foreign distribution to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1341-2020
- UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardi
Terminated Class II Medical devices
- Recall started
- 16 October 2019
- Terminated
- 30 April 2020
- Reason
- There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.
- Distribution
- The devices were distributed to the following US states: CA, FL, GA, IA, IN, MD, MT, NC, NY, OH, OK, SD, TN, TX, WY, and PR. The products were distributed to the following foreign countries: Brazil and Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0271-2020
- Hitachi Scenaria Whole-body X-ray CT System
Terminated Class II Medical devices
- Recall started
- 29 June 2018
- Terminated
- 27 April 2020
- Reason
- The firm received a complaint where, during patient positioning, the technologist was adjusting the patient table height and the table failed to stop when the control was released and contacted the CT gantry. The problem could not be duplicated at the site, so to avoid further issues while a root cause investigation was pursued, Hitachi choose to add an optional touch sensor to the gantry to add a redundant level of protection. It is conceivable that a patient s extremity may be caught between the tabletop and the gantry surface during uncontrolled motion or that the table contact of the gantry might cause internal damage to the unit.
- Distribution
- US Distribution to one customer in TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2839-2018
- Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in e
Terminated Class II Medical devices
- Recall started
- 18 June 2018
- Terminated
- 20 April 2020
- Reason
- The stainless steel belt which runs the length of the table underneath the tabletop is exposed when the tabletop is extended into the magnet for scanning. The firm has received two complaints where technologists have cut their fingers on this belt.
- Distribution
- Worldwide Distribution - US Nationwide distribution.in the states of Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2479-2018
- Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ioni
Terminated Class II Medical devices
- Recall started
- 20 October 2017
- Terminated
- 16 April 2020
- Reason
- The ultrasound probe may not have adequate protection against electrical shock hazards.
- Distribution
- Distributed in 21 states: AR, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NY, OK, OR, PA, SC, TX, VA, WA, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0816-2018
- Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.