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Terminated

DPX-MD series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD.

FDA Recall Z-0603-2010 · Posted 2010-01-27

Recalling FirmGe Healthcare
Recall StatusTerminated
Product CodeKGI
Date Initiated2009-02-01
Date Terminated2011-12-31
Product Quantity1,764 total

Reason for Recall

Failure to properly pre-indicate the technique factors to be used during a patient scan.

Firm Action

An Important Electronic Product Radiation Warning letter will be sent to customers. The letter will discuss the defect description and related hazards, the affected product details, safety instructions, and product correction. Customers are to contact their local GE Healthcare service representative with questions.

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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