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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00802-3
Product Name/Description Innova 2121IQ and Innova 3131IQ Cardiovascular X-Ray Imaging Systems (diagnostic fluoroscopic angiography x-ray system)

ARTG Number: 93871
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 6/08/2012
Responsible Entity GE Healthcare Australia Pty Ltd
Reason/Issue While performing a fluoroscopic acquisition with the Innova 2121IQ or Innova 3131IQ systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover. It may happen in a very specific scenario when one operator is requesting a LIH (last image hold) functionality and another operator starts a short fluoroscopy exposure (stopping fluoroscopy exposure within 2 seconds) without waiting for the display of the LIH (last image hold) in review monitor. The user would need to restart the system in order to regain acquisition capability.
Recall Action Recall for Product Correction
Recall Action Instructions GE Healthcare is providing work around instructions to mitigate the risk and will be implementing a software update to permanently correct the issue.
Contact Information 1800 659 465 - GE Customer Care Centre