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Terminated

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.

FDA Recall Z-0959-2015 · Posted 2015-01-13

Recalling FirmSun Nuclear Corporation
Recall StatusTerminated
Product CodeIYE
Date Initiated2014-08-08
Date Terminated2015-03-23
Product Quantity6 Units.

Reason for Recall

Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.

Firm Action

Sun Nuclear Corp. sent a memo dated 08/08/2014 to their 3 customers of the possible manufacturing error.

Root Cause

Use error

Distribution Pattern

Distributed in the states of CA, CO, and OH.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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