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Terminated

Phoenix x/ray inspector series. Phoenix x|ray inspector series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology.

FDA Recall Z-1826-2011 · Posted 2011-04-06

Recall StatusTerminated
Product CodeRCE
Date Initiated2009-03-16
Date Terminated2017-04-17
Product Quantity118 units total

Reason for Recall

Some of the systems do not have a safety interlock on the service access panel. Although the systems have two independent means for indicating when x-rays are being generated, some systems may have one indicator that is not discernible. Also, some systems lack proper placement of a caution label and others do not have this label affixed.

Firm Action

The firm has completed all of the following necessary actions and no further actions have been indicated: A Field Service Memo was issued to customers. It described the affected product and described the issue. GE Sensing and Inspection provided and installed retrofit kits, and the systems in question were tested by qualified Field Service Engineers at no charge to customers. GE asked customers to post the notification letter on the affected equipment until retrofit was completed. Questions were to be directed to the GE Service Center at 800-766-6062.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

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

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