Recall Z-0959-2015— Sun Nuclear Corporation
Class II · Terminated
Class II FDA medical device recall by Sun Nuclear Corporation, initiated 2014-08-08, terminated 2015-03-23. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment..
- Recalling firm
- Sun Nuclear Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-08
- Terminated
- 2015-03-23
- Firm location
- Melbourne, FL, United States
Product description
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.
Reason for recall
Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.
Data sourced from openFDA. This site is unofficial and independent of the FDA.