| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00944-1 |
| Product Name/Description |
BrightView XCT
(SPECT/CT diagnostic imaging system)
Model Numbers: 882482 and 882454
ARTG Number: 117440
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
Philips received a report from the field that the flat panel detector (FPD) sensor reported to the operator that the panel was unlatched at the 0 degree position during setup. The operator attempted to manually relatch the FPD as it remained in the 0 degree position. In trying to restow the FPD, it fell from its stowed position and contacted the patient's leg and the technologist's arm. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare is advising their customers to only deploy or stow the FPD when in the +90 degrees position. Philips will be implementing a field correction to prevent the issue from occurring. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |