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Terminated

GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution XR/d with Tomosynthesis.

FDA Recall Z-1822-2008 · Posted 2008-09-25

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeKPR
Date Initiated2008-03-07
Date Terminated2011-12-11
Product Quantity127

Reason for Recall

Loss of image data: Software anomaly in the Processing Software on the Definium 8000 system may impact patient safety when using the VolumeRAD advanced application (option). The slice visualization of VolumeRAD exams acquired on the Wallstand receptor will be offset by 17mm. This prevents the visualization of anatomy WITHIN a distance of 17mm from the wallstand patient barrier (receptor cover).

Firm Action

GE sent a Product Safety Notification, dated March 7, 2008, to all customers. The letter described the safety issue, products affected, and stated that a GE Healthcare Field Engineer will schedule a visit to each facility to install a software modification.

Root Cause

Software design

Distribution Pattern

Worldwide distribution: USA, Australia, Belgium, Canada, China, Finland, France, Germany, Great Britain, Italy, Netherlands, Spain, and Sweden.

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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