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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: M001 to M028, M030 to M108, M110 to M266, M951, M952
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Hitachi Medical Systems America Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
M001 to M028, M030 to M108, M110 to M266, M951, M952
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2479-2018
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