Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-2479-2018 · Posted None

Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeLNH
Date Initiated2018-06-18
Date Terminated2020-04-20
Product Quantity264

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.

Firm Action

On June 18, 2018, the firm distributed an Urgent Medical Device Correction Notices to affected customers. Customers were informed of the issue and advised that the firm would be adding protective guards to both sides of the belt to prevent accidental contact. The firm expects to begin installing the guards around fall 2018. In the meantime, customers are advised to avoid direct contact with the stainless steel belt. Questions, comments, or requests may be sent to [email protected].

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093044OASIS MRI SYSTEMHitachi Medical Systems America, Inc. · 2010-03-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑