CLASS II Device recall · Reported 1 Feb 2017 · FDA Enforcement Report
Hitachi Oasis MRI System - C-Spine Coil recalled
Hitachi Medical Systems America is recalling Hitachi Oasis MRI System - C-Spine Coil, distributed nationwide in the US. The recall was initiated on 6 Jan 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1096-2017
- FDA event ID
- 76056
- Recalling firm
- Hitachi Medical Systems America, Twinsburg, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jan 2017
- FDA classified
- 26 Jan 2017
- Reported
- 1 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 6 Jan 2017 | Recall initiated by company | |
| 26 Jan 2017 | Classified by FDA | +20 days |
| 1 Feb 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.
Product as listed by the FDA
Hitachi Oasis MRI System - C-Spine Coil
Where it was distributed
USA (nationwide) distribution. The product was distributed to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. There are three (3) government accounts for this recall: VA Medical Center/Lyster Army Health Clinic, Parma VA Medical Center, Outpatient Clinic. There are no Canada accounts for this recall. There are no Mexico accounts for this recall.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.
Which lots are affected?
M001 to M028, M029 to M083, M085 to M090, M092 to M104, M106, M110 to M111, M113 to M114, M116 to M123, M125, M128 to M131, M133, M139 to M141, M143 to M147, M150, M152, M154, M159, M161, M163, M166, M169 to M176, M179, M182, M183, M185, M186, M190, M194 to 196, M201, M207 to M238
Where was it sold?
USA (nationwide) distribution. The product was distributed to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY. There are three (3) government accounts for this recall: VA Medical Center/Lyster Army Health Clinic, Parma VA Medical Center, Outpatient Clinic. There are no Canada accounts for this recall. There are no Mexico accounts for this recall.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hitachi Medical Systems America
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|---|---|---|---|---|---|
| Device | CLASS II | Ultrasonic pulsed doppler imaging system recalled | Hitachi Medical Systems America | Potency & Assay | Nationwide |
| Device | CLASS II | UST-2265-2 Probe recalled by Hitachi Medical Systems | Hitachi Medical Systems America | Other | 8 states |
| Device | CLASS II | Hitachi Scenaria Whole-body X-ray CT System recalled | Hitachi Medical Systems America | Device Malfunction | 16 states |
| Device | CLASS II | Hitachi Scenaria CT system recalled by Hitachi Medical Systems | Hitachi Medical Systems America | Device Malfunction | TX |
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|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |