Ingenuity CT System (2015-02-19)

Starting date:

February 19, 2015

Posting date:

March 20, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-52587

• Reason
• Affected products

Recalled products

1. Ingenuity CT System

Reason

Philips has become aware of the following issues:

Slab viewer longitudinal location issue - it is possible for the system to invert the sign (positive/negative) of the longitudinal position value displayed on an axial scan image. The following key events must take place for harm to occur:

•  The patient is placed in a "feet-first" orientation.
•  An interventional CT procedure is scheduled.
• Contrary to typical clinical practice, a multi-planar reconstruction (MPR) is used for planning the interventional procedure (this issue only occurs in images produced using MPR).
•  A check scan is not performed (normal clinical practice indicates the use of a check scan before beginning an interventional procedure).
•  The needle tip placement is not confirmed as directed (this practice would prevent more than a minimal ingress of an intervention at an undesired location).
•  Fast get ready issue - fast get ready incorrectly enabled during service procedures.
•  Contrast annotation issue - contrast annotation incorrectly missing for some images when manual contrast was administered.
•  Dot artifact issue - dot artifact present, intermittently, after startup.
•  Heart rate update issue - heart rate measured value incorrectly remains constant for some heart rate change conditions.
•  Doseright issue - doseright incorrectly enabled when the exam card specified disabling doseright.
• Tube heat issue - tube heat predictor fails to warn of overheat condition for long scans.

Affected products