Recall Z-0959-2015 ยท IYE Accelerator, Linear, Medical
Sun Nuclear Corporation
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.
| Date | Jan 13, 2015 (initiated Aug 8, 2014) |
| Status | Terminated |
| Reason | Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment. |
| Root cause | Use error |
| Action | Sun Nuclear Corp. sent a memo dated 08/08/2014 to their 3 customers of the possible manufacturing error. |
| Quantity | 6 Units. |
| Distribution | Distributed in the states of CA, CO, and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.