Brilliance 40/40 Slice CT System and Ingenuity CT System (2017-10-12)

Starting date:

October 12, 2017

Posting date:

October 27, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Hospitals, Healthcare Professionals

Identification number:

RA-64960

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  Reason
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  Affected products

Affected Products

1. BRILLIANCE 40/40 SLICE CT SYSTEM
2. INGENUITY CT SYSTEM

Reason

Issue 1: Cardiac Signal not found in Workflow Issue-

If the operator loads a Cardiac Exam Card, the cardiac signal is shown during cardiac scan but not shown during the surview.

Issue 2: Scan may start at the top of the head, which may not be where the operator is expecting the scan to start. If the operator plans to do multiple scans with multiple results including identical links, then the first result of the subsequent acquisition will follow the last result of previous acquisition and not the identical link of the previous acquisition. The possible outcome is that the results of the second scan could be planned outside the boundaries of the expected results.

Issue 3: Pulmo Gates on Cardiac Workflow Issue -

If the operator loads a Cardiac Exam Card after performing a Pulmonary scan, the Pulmo wave may be present.

Issue 4: In the Plan viewer if the start position is modified the total length of the acquisition will changes as well. In the Plan viewer if the start position is modified by the length of one slice thickness, then the total length of the acquisition may change by the same length value as well. Note this occurs only when planning without a surview.

Issue 5: Image volumes are not found in patient directory when thin images are included in one of the multiple results. The operator completes a CT Orbit procedure and clicks ‘End Study’. The final thin images may not appear in Patient Directory. When the operator clicks ‘Recon’ to attempt to do an off-line recon the ‘View 2’ application may fail.

Issue 6: Application may fail when modifying the results Plan Box during 3D Calcium Score

While setting up a 3D Calcium Score scan, if the Operator attempts to modify the plan box of a result on the surview, the application may fail and require a restart.

Issue 7: Tube too hot-

The Operator presses ‘Go’ to execute a timed scan sequence and the following message may display: “Tube Too Hot”.

Issue 8: Memory overflow Issue-

When performing a CT clinical procedure, it is possible that the scan may be aborted as a result of a memory overflow issue.

Issue 9: While the reconstruction is in progress disconnecting the Recon box (CIRS) may not give error message. When the connection between Host computer and recon box (CIRS) is disrupted during reconstruction, the operator may not be informed and may require that the operator reconstruct the images through Off-line reconstruction.

Issue 10: Issue with the GeneratorMonitor state machine in RHost code -

When the operator turns the key switch on the CT box to ‘Off’ and turns it back on before the system gantry is turned off completely the system might make the generator to go into a configuration state and ceases to monitor and to send the updated real time data for the tube’s kV and mA.

Affected products