Brightview Gamma Camera Systems (2014-11-07)

Starting date:

November 7, 2014

Posting date:

November 20, 2014

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-42199

• 
  Reason
• 
  Affected products

Recalled Products

1. Brightview Gamma Camera System with 3/8" Crystal
2. Brightview Gamma Camera System. W/ 3/8" Crystal & Detector Caudal Cephalic Tilt
3. Brightview XCT Imaging System-Tilt System
4. System, Brightview X with crystal, 3/8" (upgradeable version)

Reason

Several software issues which will be corrected with the release of a new software version. 1-following a cardiac scan and when using smart step to setup the camera for a relative 180 procedure, it is possible for detector 1 to collide with the head holder when moving from the position at which the flat panel is deployed. This affects only the Brightview XCT systems. 2-during a patient spect lung acquisition, the clinical scan acquisition protocol commanded the gantry rotation to move from the 45 degree to the 90 degee position. However, in the middle of a clinical scan acquisition, the detector heads moved away from the patient (centre of rotation) in an uncommanded motion and subsequently the gantry unexpectedly rotated to the 240 degree position. The movement from 90 degrees to the 240 degrees may take approximately 7 seconds. 3-at the completion of a thyroid procedure, the operator executed the pinhole pre-programmed motion (PPM) and noticed a change in the sequence of motions between the imaging pallet and the detector radius. The system moved the patient pallet from the gantry before the detector installed with the pinhole collimator was moved out of the path of the patient. This sequence of motions differed from the previous software release. This affects systems with software version 1.2.3/2.5.3.

Affected products