| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01171-1 |
| Product Name/Description |
Philips IntelliVue Patient Monitors ECG 12-lead option #C12
(with the combination of s/w version (J.0, J.1, K.2, L.0) and ECG Firmware revision E.01.22)
Affected Products:
IntelliVue Multi Measurement Server
Product Number: M3001A
IntelliVue Multi Measurement Server SLCP
Product Number: M3001AL
IntelliVue Multi Measurement Server X2
Product Number: M3002A
IntelliVue MP2
Product Number: M8102A
IntelliVue MP5
Product Number: M8105A
ARTG Numbers: 118076 and 213953 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Philips has identified that ST-segments in a 12-lead ECG may become distorted and the ST-value may be inaccurate when an affected monitor automatically activates ECG filtering in the event that a “ECG Check Cable” or “ECG Noisy Elec xx” INOP condition is triggered and displayed. These INOPs are triggered when the monitor detects a low impedance between ECG lead wires and the cable shield in the lead set, which can be caused by mechanical damage or fluid ingress.
Distortions on the ST-segment and associated numerics can contribute to a misdiagnosis or misinterpretation, which can cause a delayed or an incorrect treatment. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are to complete and return the supplied acknowledgment form.
Until the software is updated, users are to ensure that the “ECG Check Cable” or “ECG Noisy Elec xx” INOP is actioned following the instructions in the corresponding IFU.
A Philips Healthcare representative will contact customers with affected devices to arrange a software update to correct the issue.
This action has been closed out on 18/02/2019 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |