| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00432-1 |
| Product Name/Description |
Philips Allura Xper X-Ray Systems
Allura Xper and Allura CV20 Releases 3 to 8.1 with an installed Laird chiller
Allura Xper Release 8.2: only configurations FD10, FD10/10, FD20/10, FD20/20 have a Laird chiller
Multiple Product Names and Codes
ARTG Number: 225815 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
Through customer complaints, Philips has discovered problem with the detector cooling system for a limited number of Allura Xper and Allura CV20. Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R-cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odour, smoke or fire. To date, Philips is not aware of any injuries that may have occurred as a result of this problem. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising users that if a burning odour, smoke or fire is detected coming from the technical room, the main switch should be turned off and system taken out of service immediately. In the event of a hazardous situation, users are requested to adhere to their workplace emergency procedures. Once any hazardous situation has been abated, users are advised to inform their local Philips representative. (Please note: Philips will start inspecting affected systems for leaks and repair as required. In addition as from April 2017, Philips will undertake a free installation of an extended drip tray on affected systems to prevent damage from any future leaks).
This action has been closed out on 13/11/2018 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |