| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00049-1 |
| Product Name/Description |
BrightView, BrightView X, BrightView XCT, Precedence 6, Precedence 16
Product Number - 8823500 Precedence 16
Product Number - 882351 Precedence 6 Slice
Product Number - 882478 BrightView X
Product Number - 882480 BrightView SPECT
Product Number - 882482 BrightView XCT
ARTG Number: 117440 (Philips Electronics Australia Ltd - SPECT/CT diagnostic imaging system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified an issue during collimator exchange that may result in the collimator falling from the detector head or collimator cart. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips is directing users to the warnings outlined in the IFU for BrighView regarding collimator exchange.
Philips is advising customers to stay clear of moving parts during collimator exchange, other than the interaction required to dock/undock collimator carts with the system.
It is recommended that the technologist keep their feet out from under the collimator carts while docking / undocking them with the camera.
It is further recommended that the technologist observe the system during collimator exchange, and press an E-stop button if something occurs that is unexpected / not as described in the IFU.
Philips is updating Preventative Maintenance Procedures to check for and correct any misalignment and/or loose parts associated with collimator exchange.
This action has been closed out on 10/07/2019 |
| Contact Information |
1800 251 400 - Support Service Centre |