BRIGHTVIEW GAMMA CAMERA AND XCT IMAGING SYSTEMS (2015-12-17)

Starting date:

December 17, 2015

Posting date:

January 14, 2016

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-56648

• Reason
• Affected products

Affected Products

A. BRIGHTVIEW GAMMA CAMERA SYSTEM WITH 3/8" CRYSTAL
B. BRIGHTVIEW GAMMA CAMERA SY. W/ 3/8" CRYSTAL & DETECTOR CAUDAL CEPHALIC TILT
C. BRIGHTVIEW XCT IMAGING SYSTEM - TILT SYSTEM
D. SYST, BRIGHTVIEW X WITH CRYSTAL, 3/8"(UPGRADEABLE)

Reason

Philips has become aware of several software issues which will be corrected with the release of a new software version. Issue 1: during a cardiac non-auto body contouring (ABC) scan, using cardiac high resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Scan interruption may lead to the need for rescan or reinjection of radiopharmaceuticals. Issue 2: during a scan, the gantry motion may halt prematurely. This causes the scan sequence to pause. Incidences of scan sequence pause have been reported to occur more often after installation of the following software: - version 1.2.4 for BrightView. - version 2.5.4 for BrightView X, and BrightView XCt. Issue 3: the operator will receive a warning message indicating that the scan may not complete when defined with the following scan parameters:-detector relative angle: 90 and  head first supine or feet first prone this message further instructs the operator to re-mark the points used to define the orbit. Issue 4: -the resolved defects section of the user release document 1.2.4/2.5.4 for BrightView, BrightView X and BrightView XCT (45980022532 Rev A) listed two pre-programmed motions (PPMs) whose motion sequences were changed by the release of software version 1.2.4/ 2.5.4. The software has been updated so that the patient table is extracted before detectors are in motion.  In addition to the two PPMs in the user release document, the following 31 PPMs have also changed motion sequence:   -DH Hands Left, - DH Hands Right, - DH Sitting, - DH Standing,  -  Install Head Holder*, -  Remove Head Holder*, - Anterior Oblique 30, - Posterior Oblique 30, - Anterior Oblique 60, - Posterior Oblique 60, - Anterior Oblique 45, - Posterior Oblique 45, -  Seated Plantar, - SH Posterior DET 1, - SH Posterior DET 2, - Planar, -  Pallet Change, - Outerroom DET 1 Left, - Outerroom DET 1 Right, - Outerroom DET 2 Left,  - Outerroom DET 2 Right, - Bed Imaging, - REL 90 Test Spin**, REL 180 Test Spin**, -Pinhole***, - Pinhole Anterior*, Pinhole Posterior*, - Lung -Pallet in, - Lung -Rotate CW 45?, - Lung -Rotate CCW 45, - Lung -Pallet Out, - Applicable only to BrightView X and BrightView XCT, Applicable only to BrightView XCT, - Applicable only to BrightView.

Affected products