| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00177-2 |
| Product Name/Description |
SureSigns VSi, VS2+ products
All devices manufactured between December 15, 2016 and May 02, 2017
Model: SureSigns VSi - NBP
Product: 863275
Model: SureSigns VSi - NBP/SPO2
Product: 863276
Model: SureSigns VS2+ NBP/SPO2
Product: 863278
Multiple Serial Numbers
ARTG: 93971
(Philips Electronics Australia Patient monitor, multiparameter) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
27/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Phillip has identified that certain SureSigns VSi, VS2+ products labels have a printing error on the Date of Manufacture.
This action supersedes RC-2017-RN-01263-1 regarding an error in printing of the Date of Manufacture on the same devices. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips is advising that the affected products may continue to be used because this Date of Manufacture information on the serial number label, does not impact any of device function or operation.
Philips will provide a new label with no printing error for the Date of Manufacture for each affected unit. An instruction will be provided to the impacted customers on how to perform the correction. A Philips Healthcare representative will contact users to arrange for the correction.
This action has been closed out on 09/07/2019 |
| Contact Information |
1800 251 400 - Philips Customer Service Support |