Drug recall
IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical…
FDA recall event 69751 · Class II · Sun Nuclear Corporation
Key facts
| Event ID | 69751 |
|---|---|
| Recall numbers | Z-0959-2015 |
| Recalling firm | Sun Nuclear Corporation |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment. |
| Initiation date | Aug 8, 2014 |
| Report date | Jan 21, 2015 |
| Termination date | Mar 23, 2015 |
| City | Melbourne |
| State | FL |
| Country | United States |
| FEI number | 1038814 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: