Revolution CT (2018-10-17)

Starting date:

October 17, 2018

Posting date:

November 15, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68218

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  Reason
• 
  Affected products

Affected products

Revolution CT

Reason

GE Healthcare has become aware of a localization error on revolution CT systems equipped with the smartstep option. The z location displayed on image annotation and on the gantry display may not be the actual location of the table. This can occur if:

1. The table has been moved all the way out of the gantry using the 'out' button on the gantry control or the 'unload pedal'.
2. The table is then moved back into the gantry using the 'move to start location' button on the hand held controller.

In this situation, if a scan is initiated by the user, the scan may be acquired in the wrong location. An additional scan may be necessary.

Affected products