Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Philips BrightView XCT

09 Sep 2013

The Therapeutic Goods Administration (TGA), Australia posted a medical device safety alert concerning BrightView XCT manufactured by Philips Healthcare (Model numbers 882482 and 882454).

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 zero degree position during setup. The operator attempted to manually relatch the FPD as it remained in the zero 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.

The manufacturer advises customer to keep the FPD in the deployed position until the implementation of the appropriate field safety correction.

For details, please refer to TGA website
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00944-1

If you are in possession of the product, please contact your supplier for necessary actions.

Posted on 9 September 2013

Back