| TGA Action ID |
RC-2026-RN-00448-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Philips Avalon Fetal Monitor
Philips Avalon FM20 Fetal Monitor
Product Number: M2702A
Philips Avalon FM30 Fetal Monitor
Product Number: M2703A
Serial Numbers: DE79646750, DE79646752, DE79646756, DE79646759, DE79646761, DE79646751, DE79646804 and DE79569390 |
| ARTG Number |
99202 |
| Unique Device Identifier (UDI) |
00884838000407, 00884838000414 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
During manufacturing for a specific subset of FM20 and FM30 Avalon Fetal Monitors, the speaker assembly cable contacts were inserted in the wrong orientation. This may result in the locking nose at the end of the cable failing to engage, and allow the cable to be pulled out, resulting in intermittent or permanent loss of speaker output. If this occurs, visual alarms will remain present, but audible tones and alarms will not sound.
If users do not routinely have fetal heart rate tones enabled, it may take longer for a speaker malfunction to be identified. In the worst case scenario this could resulted in delayed treatment leading to death. If audible fetal heart rate tones are enabled, this provides an opportunity to identify the problem promptly. |
| Instructions for Customers/Users |
A representative will contact customers to arrange a part replacement.
In the interim, customers are to:
- Ensure fetal heart rate tones are enabled on the Avalon Fetal Monitor until the planned correction is implemented.
- Any sudden loss of tone must prompt evaluation of the patient and the device.
- If an Avalon Fetal Monitor fails to produce any tones or audible sound, take it out of service and contact Philips immediately. |
| Action Commencement Date |
26/06/2026 |
| Responsible Entity |
|
| Contact Information |
1800 251 400 - Philips Service Delivery Team |