Reported Feb 1, 2017 · Terminated
Hitachi Oasis MRI System - C-Spine Coil
Hitachi Medical Systems America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hitachi Medical Systems America Inc · 1959 Summit Commerce Park · Twinsburg, OH · 44087-2371
Is this the product you have?
- Hitachi Oasis MRI System - C-Spine Coil
- Lot codes and dates
M001 to M028M029 to M083M085 to M090M092 to M104M106M110 to M111M113 to M114M116 to M123M125M128 to M131M133M139 to M141M143 to M147M150M152M154M159M161M163M166M169 to M176M179M182M183M185M186M190M194 to 196M201M207 to M238
- Amount recalled
- 180 units
Where it was sold
Why it was recalled
The customer indicated that the coil balun was hot to the touch when removing the coil from the patient table after an exam.
This product could cause temporary or reversible health problems — stop using it.
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