Z-0959-2015 Class II Terminated
FDA device recall Z-0959-2015 was initiated by Sun Nuclear Corporation on August 8, 2014 and is designated Class II. Reason for recall: Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment. The recall status is terminated (terminated March 23, 2015). Affected quantity: 6 Units..
Recall Details
- Product Type
- Devices
- Report Date
- January 21, 2015
- Initiation Date
- August 8, 2014
- Termination Date
- March 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 Units.
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.
Distribution Pattern
Distributed in the states of CA, CO, and OH.
Code Information
Serial #'s: 92327001, 92327002, 92327003, 84118005, 84118006, 84118004, 84118001, 84118002, and 84118003