Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intende...

FDA Device Recall #Z-2479-2018 — Class II — June 18, 2018

Recall Summary

Recall Number Z-2479-2018
Classification Class II — Moderate risk
Date Initiated June 18, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Hitachi Medical Systems America Inc
Location Twinsburg, OH
Product Type Devices
Quantity 264

Product Description

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 ionizing radiation. The Oasis system produces transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the head, body, or extremities. The images produced by the MR systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

Reason for Recall

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 Pattern

Worldwide Distribution - US Nationwide distribution.in the states of Mexico.

Lot / Code Information

M001 to M028, M030 to M108, M110 to M266, M951, M952

Other Recalls from Hitachi Medical Systems America Inc

Recall # Classification Product Date
Z-1282-2021 Class II Ultrasonic pulsed doppler imaging system - Prod... Mar 1, 2021
Z-1341-2020 Class II UST-2265-2 Probe, Part Number: UST-2265-2 - Pro... Jan 31, 2020
Z-0271-2020 Class II Hitachi Scenaria Whole-body X-ray CT System Oct 16, 2019
Z-2839-2018 Class II Hitachi Scenaria CT system Product Usage: T... Jun 29, 2018
Z-0816-2018 Class II Ultrasound Transducer, Model Number: UST-5550-R... Oct 20, 2017

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.