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Terminated

GE Healthcare DISCOVERY MODEL NM/CT 670 NM/CT system

FDA Recall Z-2158-2011 · Posted 2011-07-21

Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeIWE
Date Initiated2011-01-26
Date Terminated2012-08-31
Product Quantity4

Reason for Recall

GE Healthcare has become aware of a missing laser aperture warning label (i.e. Laser Aperture - Do Not Stare Into Beam) affecting certain Discovery Systems.

Firm Action

GE Healthcare will bring affected systems into compliance. A GE Healthcare Service Representative will provide a product label correction to address this issue. This will be carried out via a Field Modification Instruction (FMVI 408311 planned to be released in June 2011 with an estimated completion date of August 2011. For questions call 262-513-4122.

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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