Reported Aug 17, 2016 · Terminated
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
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 Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
- Lot codes and dates
Serial #'s: S5002-S5014S5017-S5038
- Amount recalled
- 33 units
Where it was sold
Why it was recalled
The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient.
This product could cause temporary or reversible health problems — stop using it.
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