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Terminated

Infinia with Hawkeye 4, model numbers: H3000WC and H3000WD. GE Healthcare, Waukesha, Wisconsin 53118. Generating head and whole body CT images of human subjects

FDA Recall Z-0495-2010 · Posted 2010-01-21

Recalling FirmGE Medical Systems, LLC
Recall StatusTerminated
Product CodeJAK
Date Initiated2009-08-01
Date Terminated2012-02-04
Product Quantity343 total

Reason for Recall

Failure to provide the complete User Manual information.

Firm Action

A Field Modification Instruction will be released in February 2010. GE Healthcare will correct the Operator Manuals in forward production and the installed base units.

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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