| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2020-RN-00255-1 |
| Product Name/Description |
Philips TRx4851A Telemetry Transceivers used with Patient Information Center iX C.02.xx or C.03.01.
862231 TRx4851A 2.4 Ghz IntelliVue Tele TRX
453564052401 - ITS 2.4 PWD ECG ONLY AAMI
453564052411 - ITS 2.4 PWD ECG/SPO2 AAMI
453564052441 - ITS 2.4 PWD ECG ONLY IEC
453564052451 - ITS 2.4 PWD ECG/SPO2 IEC
453564166851 - ITS 2.4 PWD SP02 UPGRDBL AAMI
453564166861 - TELE-1.4 ITS 2.4 PWD SPO2 UPGRDBL IEC
ARTG 93971
(Philips Electronics Australia Ltd Patient monitor, multiparameter) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
23/03/2020 |
| Responsible Entity |
|
| Reason/Issue |
The ECG signal from patients being monitored using a Philips TRx4851A Telemetry Transceiver may not be properly analysed when the transceiver is used with a Philips Patient Information Centre (PIC) iX Release C.02.00, C.02.02, C.02.03 (all released versions of C.02, collectively referred to as ‘C.02.xx’) or C.03.01.
If this occurs, the Information Centre will not display a heart rate or generate, display or annunciate any heart rate or arrhythmia alarms.
Alarming based on pulse oximetry (SpO2) signals are unaffected by this issue.
Philips has confirmed that this issue is not present when Philips TRx4851A Telemetry Transceivers are used with PIIC Classic N.01.22, PIIC iX A.02.16, or PIIC iX B.02.18. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised to confirm whether PIC iX Release C.02.xx and C.03.01 is used anywhere in your facility, and if so:
1) Identify Philips TRx4851A Telemetry Transceivers in your facility by using the instructions provided in the customer letter (provided by Philips to impacted customers).
2) Immediately discontinue use of the Philips TRx4851A Telemetry Transceiver.
Philips will contact all impacted customers to perform a permanent correction on affected devices.
This action has been closed out on 20/12/2023 |
| Contact Information |
1800 251 400 - Philips Customer Service |