Reported Jan 21, 2015 · Terminated
IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical purposes to…
Sun Nuclear Corporation
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: Sun Nuclear Corporation · 3275 Suntree Blvd · Melbourne, FL · 32940-7514
Is this the product you have?
- IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.
- Lot codes and dates
Serial #'s: 9232700192327002923270038411800584118006841180048411800184118002and 84118003
- Amount recalled
- 6 Units.
Where it was sold
Why it was recalled
Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.
This product could cause temporary or reversible health problems — stop using it.
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