Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 19, 2015
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 spat
The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Hitachi Medical Systems America Inc recalled Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasi… - a moderate-severity action.
Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasi… was recalled by Hitachi Medical Systems America Inc in August 19, 2015. Reason: The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard …. Check the official notice for the remedy. Verify recall #Z-2366-2015 with the FDA Devices before acting.
The recall
Hitachi Medical Systems America Inc issued this moderate-severity FDA Devices recall-The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard ….
- Moderate
- severity level
- 173 units
- affected scope
- Class II
- classification
- August 19, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2366-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2366-2015) was formally reported on August 19, 2015, with the manufacturer initiating the action on April 25, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Hitachi Medical Systems America Inc is listed as the recalling firm, operating out of Twinsburg, OH. Federal records list the affected scope as 173 units.
The documented reason for this recall is: The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
173 units
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2366-2015 |
| Date reported | August 19, 2015 |
| Date initiated | April 25, 2014 |
| Recalling firm | Hitachi Medical Systems America Inc |
| Firm location | Twinsburg, OH |
| Affected scope | 173 units |
| Distribution | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2366-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hitachi Medical Systems America Inc. Units affected: 173 units.
Why was this product recalled? ▼
The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard if touched.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 19, 2015. Severity: Moderate. Recall number: Z-2366-2015.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2366-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 19, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.