| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00707-1 |
| Product Name/Description |
Siesta i TS machine
(P/N # 866163/10653-00) with a serial number within the following range:
200550022 to 200949001
AM5153237 to AM5156683
DK25100001 to DK43000256
ARTG Number: 176848 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
During internal review, Philips identified that it was not explicitly described in the Instructions for Use that the O2 test must be done as part of the daily check to ensure that the machine measures the O2 concentration in the fresh gas correctly, and can deliver the desired O2 concentration in the fresh gas to the patient.
Incorrect measurement of O2 concentration in the fresh gas or O2 concentration in the fresh gas not at desired level, can potentially cause hypoxia to the patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Review the Recall for Product Correction and the update to the IFU and ensure that the changes are understood and that all personnel using the device are informed about the content in this Recall for Product Correction. This action has been closed-out on 17/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |