Z-2479-2018 Class II Terminated
FDA device recall Z-2479-2018 was initiated by Hitachi Medical Systems America Inc on June 18, 2018 and is designated Class II. 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 te… The recall status is terminated (terminated April 20, 2020). Affected quantity: 264.
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2018
- Initiation Date
- June 18, 2018
- Termination Date
- April 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
Code Information
M001 to M028, M030 to M108, M110 to M266, M951, M952