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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01541-1
Product Name/Description Ingenuity TF PET/CT running software version 4.0.2 (

Model: 882442

ARTG Number: 292543
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 21/12/2017
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue Philips has identified a software issue causing PET reconstructions to fail intermittently. It was determined that reconstructions fail due to a negative table position (-1 value is inserted) in the raw data list file, rather than the actual table position.
This error has been found to occur in two scenarios resulting in acquisition data that will not be able to be reconstructed and will therefore be unusable:
1) When the system operator cancels an acquisition
2) Couch position requests within the software sequence were delayed
a. The error occurs intermittently, but has been found to occur more frequently when the gantry’s network is heavily loaded with multiple retrospective reconstructions running in parallel.
b.The error manifests to the technologist by an error message and Failed status on the Reconstruction Monitor and the error message “Result {0} failed to reconstruct” on the Acquisition Workflow window during reconstruction after the patient scan has been completed.
Recall Action Recall for Product Correction
Recall Action Instructions It is recommended that the technologist follow the Warning provided in the Instructions for Use - System Information for Ingenuity TF 459800079321 Rev B, Section 2 Safety Guidelines, pg 2-17 and that the patient remains in the original scan position until reconstructed images are verified.
Philips will be releasing a correction for this issue. A Philips Field Service Engineer will contact users to schedule the update.
Contact Information 02 9947 0240 - Philips Customer Care