| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00494-1 |
| Product Name/Description |
IntelliVue MX40 with software revisions B.05, B.06 and B.06.5X
Product Numbers: 865350, 865351, 865352 and 867146
ARTG Number: 99204 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
21/05/2018 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified that five warning statements are missing from the Instructions For Use (IFU) for IntelliVue MX40 IFU software revisions B.05, B.06 and B.06.5X. If users are unaware of the hazards or limitations described in the missing warning statements, they may not properly assess or provide appropriate treatment to a patient being monitored using an IntelliVue MX40.
These IFUs are missing warning statements related to monitoring of patients with pacemakers and the interpretation of QT/QTc measurements that were present in earlier revisions of the IFU. A “Warning” alerts users to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in death or serious injury to a user or patient.
To date, no patient harm has been reported as a result of this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Phillips will contact affected customers to provide a copy of an Instructions For Use (IFU) Errata. Customers are requested to attach the Errata Sheet to the first page of Chapter 6 of the IFU.
This action has been closed out on 14/02/2019 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |