Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product… — Class II medical device recall Z-2366-2015
Terminated recall by Hitachi Medical Systems America Inc, reported 2015-08-19, distributed nationwide. The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard i
| Recall number | Z-2366-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hitachi Medical Systems America Inc, Twinsburg, OH, United States |
| Recall initiated | 2014-04-25 |
| Classified | 2015-08-10 |
| Reported by FDA | 2015-08-19 |
| Terminated | 2018-08-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 173 units |
| Reason classes | device malfunction |
| Serial numbers | M001TO, M108, M110, M175, M951, M952 |
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 for recall
The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2366-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.