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Terminated

Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis 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 cross-sectional 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. The Coil Extension Cable that is the subject of the removal action is an accessory that is used in conjunction with certain anatomy coils to aid in patient positioning.

FDA Recall Z-2366-2015 · Posted 2015-08-10

Recalling FirmHitachi Medical Systems America Inc
Recall StatusTerminated
Product CodeMOS
Date Initiated2014-04-25
Date Terminated2018-08-24
Product Quantity173 units

Reason for Recall

The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.

Firm Action

Hitachi sent an Urgent: Device Removal Notice letter date April 24, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers to discontinue using the Coil Extension Cable and that a Field Service Engineer will schedule a visit to remove the cable. For questions call 800-800-3106 ext 3720.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide in the states: AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI & WY and the country of Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072279MAGNETIC RESONANCE DIAGNOSTIC DEVICEHitachi Medical Systems America, Inc. · 2007-09-21

Official Source

View FDA Recall →

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

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