Hitachi Medical Systems America Inc

Complete recall history across all FDA and CPSC categories — 17 total recalls

Hitachi Medical Systems America Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (17)

FDA medical device enforcement actions by Hitachi Medical Systems America Inc

Date Product Reason Class
Mar 1, 2021 Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by... Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the foc... Class II
Jan 31, 2020 UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 pro... These 18 probes may have mis-wiring in the inner cables, causing decreased se... Class II
Oct 16, 2019 Hitachi Scenaria Whole-body X-ray CT System There is a possibility that the cables to the controller unit may not be affi... Class II
Jun 29, 2018 Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indic... The firm received a complaint where, during patient positioning, the technolo... Class II
Jun 18, 2018 Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging d... The stainless steel belt which runs the length of the table underneath the ta... Class II
Oct 20, 2017 Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with ... The ultrasound probe may not have adequate protection against electrical shoc... Class II
May 2, 2017 Arietta 70 Ultrasound System Intended for use by trained personnel (doctor... The strength of the arm mounting mechanism was insufficient and had to be red... Class II
Jan 6, 2017 Hitachi Oasis MRI System - C-Spine Coil The customer indicated that the coil balun was hot to the touch when removing... Class II
Jun 30, 2015 Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America,... The firm discovered that the centrifugal force applied to the power supply ma... Class II
Apr 16, 2015 Hitachi Echelon Oval MRI System Image data transferred from the MRI system to a workstation showed errors on ... Class II
Apr 16, 2015 Hitachi Oasis MRI System Image data transferred from the MRI system to a workstation showed errors on ... Class II
Apr 16, 2015 Hitachi Echelon MRI System Image data transferred from the MRI system to a workstation showed errors on ... Class II
Aug 18, 2014 Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per ... The Gradient Coil was found to have a failure mode that allowed it to overhea... Class II
Apr 25, 2014 Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usag... The firm received a complaint stating the Coil Extension Cable accessory woul... Class II
Jan 31, 2013 Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. ... Hitachi discovered a software error that can occur when simultaneously scanni... Class II
Jun 15, 2012 Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled... Hitachi discovered a software error with a feature called Multi-Planar Recons... Class II
May 4, 2012 Hitachi Scenaria CT System Software Product Usage: The Scenaria system is... Hitachi discovered a software error in the Reconstruction Status function tha... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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