Device safety informationMHRA
Radiofrequency (RF) Safety Considerations safety warning over a software fault
The MHRA has conducted a review into the use of wireless cardiotocography (CTG) systems that use radiofrequency (RF) telemetry channels. Signal crossover, erroneous CTG traces and signal dropouts have been identified as patient safety risks associated with these devices.
What to do now
The issue with Radiofrequency (RF) Safety Considerations is in its software or user interface.
- Speak to the clinic, hospital or supplier who gave you the device before changing how you use it.
- Check the model, lot or serial number against the details on this page.
- Any incident involving the device can be reported through the Yellow Card scheme.
Why it matters. Software faults can lead to wrong readings, missed alarms or incorrect settings.
Replacements and support
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next.
Do not throw away a device you rely on until a replacement has been arranged.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2026/012). Quoted as issued.
Summary
The MHRA has conducted a review into the use of wireless cardiotocography (CTG) systems that use radiofrequency (RF) telemetry channels. Signal crossover, erroneous CTG traces and signal dropouts have been identified as patient safety risks associated with these devices.
The risk
Summary The MHRA has conducted a review into the use of wireless cardiotocography (CTG) systems that use radiofrequency (RF) telemetry channels. Signal crossover, erroneous CTG traces and signal dropouts have been identified as patient safety risks associated with these devices. In rare circumstances, signal crossover may result in the fetal heart rate from one CTG monitor being displayed on another CTG monitor operating on the same RF channel. These risks may result in misinterpretation of CTG traces and inappropriate clinical decisions which could lead to adverse consequences. The risk relates to classic telemetry systems operating within the Industrial, Scientific and Medical (ISM) frequency band where a limited number of channels are available.
Advice for healthcare professionals
The MHRA has conducted a review into the use of wireless cardiotocography (CTG) systems that use radiofrequency (RF) telemetry channels. Signal crossover, erroneous CTG traces and signal dropouts have been identified as patient safety risks associated with these devices. In rare circumstances, signal crossover may result in the fetal heart rate from one CTG monitor being displayed on another CTG monitor operating on the same RF channel. These risks may result in misinterpretation of CTG traces and inappropriate clinical decisions which could lead to adverse consequences.
The risk relates to classic telemetry systems operating within the Industrial, Scientific and Medical (ISM) frequency band where a limited number of channels are available.
ensure that two or more wireless CTG devices are not operating on the same RF channel unless there is sufficient distance between them to prevent signal crossover or interference (see under Operational Controls in the Actions for NHS Organisations section for further details). For example, in the absence of any obstacles such as walls or pillars, a distance of 100 metres may be required between two devices operating on the same RF channel to avoid signal crossover. Note that the wall between adjacent rooms may not be sufficient to prevent signal crossover. There is also the potential for signal crossover between floors. The Instructions for Use and/or manufacturer guidance should be consulted for device-specific advice on this matter
verify CTG traces clinically at the commencement and throughout the period of monitoring. Ensure CTG traces correlate with other clinical features such as:
maternal pulse;
clinical assessment of fetal and maternal condition;
verification that displayed FHR belongs to the correct patient
ensure access to a wired CTG system as a backup in the event of signal drop out or crossover
ensure RF CTG transducers are correctly docked and paired to the base station
prior to the commencement of monitoring, ensure correct transducer pairing
ensure base stations and transducers are clear of gel after each use and prior to returning to the base station or charging rack
report any suspected adverse incidents associated with these devices through the Yellow Card website , or if in Scotland to Incident Reporting & Investigation Centre (IRIC)
Open the MHRA notice
Questions
Why has Radiofrequency (RF) Safety Considerations been recalled?
The issue with Radiofrequency (RF) Safety Considerations is in its software or user interface. Software faults can lead to wrong readings, missed alarms or incorrect settings.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
Speak to the clinic, hospital or supplier who gave you the device before changing how you use it. Check the model, lot or serial number against the details on this page.
Who replaces the device?
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next. Do not throw away a device you rely on until a replacement has been arranged.