Browse Device Recalls
17 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 17 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 17 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 focus point and transdu... | Class II | Hitachi Medical Systems America Inc |
| 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 sensitivity and thus r... | Class II | Hitachi Medical Systems America Inc |
| 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 affixed properly, creati... | Class II | Hitachi Medical Systems America Inc |
| 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 technologist was adjusting t... | Class II | Hitachi Medical Systems America Inc |
| 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 tabletop is exposed wh... | Class II | Hitachi Medical Systems America Inc |
| 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 shock hazards. | Class II | Hitachi Medical Systems America Inc |
| 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 redesigned. | Class II | Hitachi Medical Systems America Inc |
| Jan 6, 2017 | Hitachi Oasis MRI System - C-Spine Coil | The customer indicated that the coil balun was hot to the touch when removing the coil from the p... | Class II | Hitachi Medical Systems America Inc |
| Jun 30, 2015 | Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America,... | The firm discovered that the centrifugal force applied to the power supply may cause it to fail o... | Class II | Hitachi Medical Systems America Inc |
| Apr 16, 2015 | Hitachi Echelon Oval MRI System | Image data transferred from the MRI system to a workstation showed errors on the slice position r... | Class II | Hitachi Medical Systems America Inc |
| Apr 16, 2015 | Hitachi Oasis MRI System | Image data transferred from the MRI system to a workstation showed errors on the slice position r... | Class II | Hitachi Medical Systems America Inc |
| Apr 16, 2015 | Hitachi Echelon MRI System | Image data transferred from the MRI system to a workstation showed errors on the slice position r... | Class II | Hitachi Medical Systems America Inc |
| 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 overheat and become a burn ... | Class II | Hitachi Medical Systems America Inc |
| 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 would overheat and be a ... | Class II | Hitachi Medical Systems America Inc |
| 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 scanning a patient while p... | Class II | Hitachi Medical Systems America Inc |
| 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 Reconstruction (MPR). MPR... | Class II | Hitachi Medical Systems America Inc |
| May 4, 2012 | Hitachi Scenaria CT System Software Product Usage: The Scenaria system is... | Hitachi discovered a software error in the Reconstruction Status function that creates a potentia... | Class II | Hitachi Medical Systems America Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.