| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01183-1 |
| Product Name/Description |
Philips BV25, BV300, BV Libra, BV Endura, BV Pulsera (Fluoroscopic x-ray systems)
System: BV25
Model Number: 718015
System: BV300
Model Numbers: 71815, 71816, 71819
System: BV Libra
Model Numbers: 718022, 718030, 718031
System: BV Endura
Model Numbers: 718071, 718072, 718073, 718074
System: BV Pulsera
Model Number: 718094
ARTG Number: 98556 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
13/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
Philips has been notified regarding an issue with the X-Ray "ON" label for systems supplied in South Australia. The colour of the exposure indicator on the control panel is same as the background text. Hence, systems do not meet South Australia's Radiation Protection and Control Regulation.
This issue has been evaluated for radiation hazard and concluded that there is no safety impact to the patient, user or bystander. It is a Regulatory non-compliance issue in South Australia. This issue has been evaluated for potential radiation hazard and concluded that there is no safety impact to the patient, user or bystander. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips will be applying a red transparent label over the existing x-ray symbol on the control panel as a permanent correction in the affected systems in South Australia. In the interim, users are advised that there is an indicator lamp on Mobile Viewing Station which glows whenever x-ray exposure happens. The user should use this indication to be able to know when an exposure happens. This action has been closed-out on 24/05/2017. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |