Recall Z-2366-2015— Hitachi Medical Systems America Inc

Name: FDA recall Z-2366-2015
Creator: U.S. Food and Drug Administration
Published: 2014-04-25

Class II · Terminated

Class II FDA medical device recall by Hitachi Medical Systems America Inc, initiated 2014-04-25, terminated 2018-08-24. It names one FDA 510(k) clearance: K072279. Product: 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.. Reason: The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched..

Recalling firm: Hitachi Medical Systems America Inc
Classification: Class II
Status: Terminated
Initiated: 2014-04-25
Terminated: 2018-08-24
Firm location: Twinsburg, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K072279 — MAGNETIC RESONANCE DIAGNOSTIC DEVICEHitachi Medical Systems America, Inc.·cleared 2007-09-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.