Brightview Gamma, XCT, and X Camera Systems (2013-12-24)

Starting date:

December 24, 2013

Posting date:

January 24, 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-37643

• Reason
• Affected products

Recalled products

1. Brightview Gamma Camera System with 3/8 inch Crystal
2. Brightview Gamma Camera System with 3/8 inch Crystal and Detector Caudal Cephalic Tilt
3. Brightview XCT Imaging System - Tilt System
4. Brightview X System with 3/8 inch Crystal (Upgradeable Version)

Reason

Philips has become aware of several software issues which will be corrected with the release of a new software version.

Problem 1: When positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned correctly by an operator, causing an inappropriate rotation orbit calculation for the patient being imaged. When the acquisition was started and the detectors began to move into position, the incorrect calculation resulted in the detectors coming in contact with the patient.

Problem 2: On separate occasions, as the gantry system was moving to a relative 90 scan position of the detectors, a patient or operator moved their hands or arms into the path of the detectors in the area of where the detectors meet resulting in the detectors coming in contact with the patient and operator.

Problem 3: While a user was manually positioning the patient for their exam and translating the pallet into the gantry bore, the pallet catcher that supports the imaging table was higher than the imaging pallet resulting in a pinch point or table tilt if not engaged with the catcher. This problem can only occur on the Brightview X or the Brightview XCT system.

Affected products