| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00079-1 |
| Product Name/Description |
CDAS upgraded Intera MR systems equipped with the Basic Triggering Unit
(Full body MRI (Magnetic Resonance Imaging) system)
Part numbers: 9065 and 9067
Units Affected: All batteries with date codes 2808 or earlier
ARTG Number: 98887 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Philips is informing the customer that the lithium polymer batteries, used in the CDAS upgraded Intera MR systems equipped with the Basic Triggering Unit may fail after being physically dropped from a height (i.e. from waist height to floor). The failed battery may momentarily produce a flame and then emit smoke, which could lead to a thermal burn to patient or operator in close proximity to the battery. The failure of the battery may occur instantly or may be delayed for a short period of time. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is providing guidelines to reduce the risk of the battery failure as well as instructions to mitigate the risk of harm in case the battery was dropped. Philips is replacing the affected batteries free of charge. This action has been closed-out on 03/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |