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Terminated

GE Definium 8000 , model 5135678, Digital Radiographic Systems. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188, U.S.A.

FDA Recall Z-1476-2008 · Posted 2008-09-18

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeJAA
Date Initiated2007-08-13
Date Terminated2010-10-07
Product Quantity448

Reason for Recall

Necessary certification labels are missing from the x-ray contol.

Firm Action

A field Engineer from GE will visit the customer site to apply label to the X-ray control.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

Worldwide including USA and countries of Italy, Japan, Spain, and Turkey.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051967REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESISGE Healthcare · 2005-08-09

Official Source

View FDA Recall →

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

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