| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01025-1 |
| Product Name/Description |
Philips IntelliVue Patient Monitors
Model Numbers: MX400, MX430, MX450, MX500, MX550
Product Codes: 866060, 866061, 866062, 8066064, 866066
ARTG Number: 213953 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
If an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain out-dated data and therefore fail to reflect the patient’s current condition. Even if out-dated waveforms are displayed as a result of this problem, the monitor’s alarms and numeric displays of vital signs will continue to function as specified and accurately reflect current patient data.
The length of time that a monitor must be powered on before the problem occurs depends on the selected wave speed. It ranges from 102 days (@50 mm/s) to 820 days (@ 6,25 mm/s), and is approximately 205 days at the monitor’s default wave speed of 25 mm/s. The monitor must be powered off in order to avoid this problem. Simply placing it in stand-by mode is not sufficient. Please note that connected devices, such as central monitors continue to display the correct wave data. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare is advising users to cycle the power on the affected devices on a monthly basis. A software upgrade will be implemented as a permanent correction.
This action has been closed-out on 27/03/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |