Device product
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.
Z-0959-2015
Product summary
- Event
- Event 69751
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 Units.
- Official record key
device-enforcement:Z-0959-2015
Official wording
Reason: Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.
Code information: Serial #'s: 92327001, 92327002, 92327003, 84118005, 84118006, 84118004, 84118001, 84118002, and 84118003
Distribution pattern: Distributed in the states of CA, CO, and OH.
Derived failure modes
-
Unknown
Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.