Skip to content
Recall Observatory FDA recall evidence

Device product

GE Healthcare Definium 5000 / 5220493 X-Ray System

Z-0703-2013

September 26, 2012

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 64134
Status
Terminated
Classification
Class II
Quantity
312 installed in US
Official record key
device-enforcement:Z-0703-2013

Official wording

Reason: When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated.

Code information: Definium Model 5000/5220493

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display different exposure techniques than selected, and may not display AEC setting. The exposure can still be made as commanded, however it may not be properly indicated.