| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01225-1 |
| Product Name/Description |
BrightView SPECT, BrightView X and BrightView XCT Systems
Software Versions at or below: V1.2.2 (Brightview SPECT and X) / V2.5.2 Brightview XCT)
ARTG number: 117440 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified the following anomalies that give rise to a potential hazard of unexpected contact between the detector and the patient:
1)Following a cardiac scan and when using SmartStep to set-up 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 issue only affects 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 degree 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 degree to the 240 degree may take approximately 7 seconds.
There have been no reports of patient injury due to either of these issues to date. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising the customer/user to perform the work-around identified in the customer communication prior to the implementation of the permanent correction, to avoid contact between the detector and the head holder. Also, they are advised to monitor the patient during all system motions and to know locations of the multiple E-Stop button(s) to halt all system motions, if required. The correction will consist of the installation of BrightView Family software version 1.2.4/2.5.4. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |