| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00122-1 |
| Product Name/Description |
Allura Xper R7.2.x (Fluoroscopic diagnostic x-ray system)
Product codes: 722003, 722005, 722006, 722008, 722014, 722015 with system software release 7.2.x
ARTG Number:175708 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound, as is required. No injuries attributed to the problem are reported. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare is advising the user to always observe realtime dose information and cumulative fluoro time provided by the system. The fault condition is reset when a new patient case is started or when the system is restarted. Philips Healthcare service engineers will install software release R7.2.8 which addresses the buzzer issue. This action has been closed-out on 3/8/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |