| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00297-1 |
| Product Name/Description |
Uninterruptible Power Supply (UPS) supplied with Philips Computed Tomography / Advanced Molecular Imaging Systems
BrightView, BrightView X / XCT
Cardio MD
Forte
Gemini TF/ GXl (6 slice) / TF Astonish/ 16 Power/ GXL / TF 64 w/ TOF Performance
Ingenuity, Ingenuity Core/ Core 128/ CT/ CT 728326/ Flex/ TF PET/CT
Precedence
Brilliance CT 16 Slice/ 64 Channel/ Big Bore Oncology/ iCT/ iCT - BETA TEST SYSTEM/ iCT SP
MX 16 Slice
ARTG Numbers: 98868, 117440, 117642, 118077, 158775 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
Without preventative maintenance, and/or periodic battery replacement, UPS devices may fail, resulting in battery acid leakage, overheating, and/or the emission of fumes. All lead/acid battery-based UPS devices are susceptible to this issue. Hazards involved as a result of UPS devices failing include, but are not limited to:
· Chemical burn
· Thermal burn
· Eye, nose and/or throat irritation |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised to review the material supplied with the customer letter and implement a UPS maintenance program at their facility.
If users detect an unusual odour, heat, or see liquid in the area of the UPS, do not touch the UPS or any surrounding liquid. Follow institution’s procedures for potentially hazardous material. Be aware of all people in the vicinity of the potentially hazardous situation, including but not limited to patients, staff, and service personnel. Contact the service provider immediately. This action has been closed-out on 09/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |